Search Results (792)

Background/Objectives: To evaluate and compare the characteristics of clinical trials (CTs) involving patients with primary Sjögren’s syndrome (pSS), using biologics, and focusing on the features of the patients recruited. Methods: This systematic review assessed pSS CTs evaluating biologic drugs published from 2010 to 2024 according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines. The literature search of the electronic databases was performed individually by the authors. The extracted variables regarding the baseline characteristics of participants and trial-related information were defined a priori, collected, and compared. Results: A total of 16 CTs were included in this review in line with the inclusion criteria. The trials were predominantly multicenter (75%) randomized controlled trials with a placebo arm (93.8%), with only five trials recruiting participants across multiple (≥3) continents. The search included a total of 1607 patients (mean age 51 years, 94% female) with a mean disease duration of 6.47 years. Race and ethnicity were underrepresented variables, found in 37.5% and 12.5% of the trials, respectively, with White patients comprising the majority (77.8%). The EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI) was reported in 93.8% of the CTs. However, only recent studies have emphasized it as the primary outcome. Conclusions: Recent trials on biologics in pSS patients show better methodological quality, with a more standardized assessment of disease activity using ESSDAI, and an increased focus on patient-reported outcomes. Global participation is increasing, but limited racial and ethnic diversity, endpoint variability, and inconsistent biomarker reporting remain critical issues. Full article

(1) Background: Sepsis is characterized by profound heterogeneity of immune responses, complicating biomarker-based prediction of clinical outcomes. Latent human cytomegalovirus (HCMV) infection is one of the strongest modulators of the human immune system and may influence cytokine-mediated signaling during sepsis. (2) Methods: In this post hoc analysis of 331 patients from the prospective multicenter SepsisDataNet.NRW cohort (German Clinical Trial Registry No. DRKS00018871), we quantified 13 serum cytokines on day 1 after sepsis diagnosis and determined HCMV IgG serostatus via ELISA. Using nested cross-validated logistic regression with exhaustive feature selection, we identified cytokine panels predictive of 30-day survival in the total cohort and in subgroups stratified by HCMV serostatus. (3) Results: In the total cohort, a four-cytokine panel (IL-6, IL-10, TNF-α, IL-12p70) predicted 30-day survival with a cross-validated area under the curve (AUC) of 0.66 [95% CI: 0.59–0.72]. Stratification by HCMV serostatus revealed distinct predictive profiles: in HCMV-seropositive patients, a two-cytokine model (IL-10, IL-23) achieved an AUC of 0.69 [95% CI: 0.61–0.77], whereas in seronegative patients, a model based on IL-8 and IL-17A failed to generalize (AUC = 0.47 [95% CI: 0.33–0.61]). Kaplan–Meier analysis confirmed a significant separation of survival curves for the HCMV-seropositive group (p < 0.001) but not for seronegative patients (p = 0.282). (4) Conclusions: HCMV serostatus defines an immunological context in which cytokine-based prediction of sepsis outcome becomes feasible. These data suggest that viral serostatus should be systematically incorporated into biomarker discovery and immunophenotyping approaches to improve the reproducibility and biological interpretability of sepsis endotyping. Full article

Background: The albumin–bilirubin (ALBI) grade provides an objective assessment of hepatic reserve, but the need for calculation by means of a formula has hampered its use at the bedside. This study aimed to develop simple cut-off values for ALBI grade and validate its performance in a large multi-center real-world cohort. Methods: A mathematical simulation evaluated every possible ALBI pair that falls within the Child–Pugh classification (CP) A range, discretized to 0.1 increments. Cut points for patient stratification without equation-based calculation were derived. Validation was conducted with the Chang Gung Research Database (CGRD), which contains data from 10 hospitals in Taiwan. Patients with same-day albumin and bilirubin measurements in 2024 were included. Results: Mathematical modeling identified clinically applicable cutoffs—albumin ≥ 4.4 g/dL or ≤3.5 g/dL and bilirubin ≥ 2.4 mg/dL—with further refinement at albumin 4.0 g/dL and bilirubin ≥ 1.0 mg/dL. Among 7583 CP-A patients, 82% were directly classifiable without computation, with consistent applicability across chronic liver disease and hepatocellular carcinoma (HCC) subgroups. Equation dependence increased only slightly in the HCC group, confirming robustness across disease severities. Conclusions: Simplified cutoff rules derived from mathematical modeling and validated in a multi-center cohort enable rapid recognition of ALBI grade in most CP-A patients. This approach enhances the clinical usability of ALBI and supports its integration into patient care, clinical trials, and treatment allocation. Full article

Background/Objectives: SA001, a mofetil-ester prodrug of rebamipide, was developed to enhance gastrointestinal absorption and systemic exposure, which was confirmed in a prior Phase 1 study. Given the limited efficacy of current symptomatic therapies for primary Sjögren’s syndrome (pSS), this trial aimed to assess whether the improved bioavailability of SA001 could translate into clinical benefits. Methods: This multicenter, randomized, double-blind, placebo-controlled Phase 2a study enrolled adults who met the 2016 ACR–EULAR criteria for pSS. The participants were randomly assigned to one of four groups: SA001 at 360, 720, or 1080 mg/day (administered twice daily for 8 weeks) or placebo. Exploratory ocular assessments included tear break-up time, ocular surface staining, the Schirmer test, and the Standard Patient Evaluation of Eye Dryness. Oral endpoints included unstimulated whole salivary flow and the Xerostomia Inventory. Anti-SSA(Ro) antibodies were assessed both quantitatively and qualitatively. Safety evaluations comprised adverse events (AEs), ophthalmic examinations, laboratory tests, and vital signs. The efficacy outcomes were exploratory, and this study was not powered to formally test efficacy hypotheses. Results: Twenty-eight women (mean age 58.54 ± 9.29 years; range 41–75 years) were enrolled in this study and randomly assigned to one of the study groups. SA001 showed no statistically significant improvements versus placebo in ocular or oral endpoints, and no consistent dose–response relationship was observed. The anti-SSA(Ro) findings did not differ meaningfully across the groups. SA001 was generally well-tolerated, with infrequent, mostly mild-to-moderate AEs; however, one serious AE occurred in the placebo group. No clinically relevant ophthalmic or laboratory safety signals were detected. Conclusions: Despite the fact that markedly increased systemic exposure has been demonstrated previously, SA001 did not improve the dryness outcomes in pSS. These findings suggest that systemic exposure alone may be insufficient in established glandular disease and highlight the need for tissue-exposure-driven strategies and biomarker-informed patient selection in future studies. Predefined primary efficacy endpoints and objective, gland-proximal measures of target engagement (e.g., standardized salivary gland ultrasonography and salivary or tear fluid biomarker assessments) may help to better interpret local pharmacodynamic activity and the likelihood of a clinically meaningful benefit. Full article

Background: Spasticity is a complex and multifactorial condition resulting from upper motor neuron injury. It manifests through muscle contractions, pain, limited range of motion, and clonus, which significantly impair daily activities and quality of life. High-frequency spinal cord stimulation (HF SCS) has shown optimal results in treating chronic neuropathic pain, but its potential role in spasticity remains underexplored. This study aimed to evaluate the efficacy of HF SCS in patients with spasticity. Methods: From April 2021 to July 2024, six patients with spasticity from various etiologies underwent SCS implantation at our institution. Clinical evaluations including the use of the Visual Analog Scale (VAS), Douleur Neuropathique 4 (DN4), and the Ashworth score, as well as ambulation ability and clonus episodes, were performed preoperatively and at a minimum of six months post-surgery. Subjective assessments of motor function, including coordination, movement efficiency, and postural transitions, were also recorded. Results: The mean age of patients was 50.12 ± 9.41 years, with follow-up averaging 24.32 ± 10.83 months. Statistically significant improvements were observed in VAS (p = 0.0412) and DN4 (p = 0.0422) scores, alongside a reduction in clonus episodes. All patients reported subjective improvements in coordination, movement efficiency, and postural transitions. Ambulation remained stable or improved in all cases. No perioperative complications or sensory/motor side effects were noted. Conclusions: HF SCS offers a promising approach to managing spasticity, with improvements in motor function, ambulation, and postural transitions. These findings support further investigation into HF SCS for spasticity, with multicenter trials needed to optimize treatment protocols and identify the most responsive patient populations. Full article

Background/Objectives: Severe COVID-19 is marked by IL-6-driven inflammation, endothelial injury, and dysregulated coagulation. Although IL-6 antagonists improve clinical outcomes, their effects on the temporal evolution of coagulation and fibrinolysis remain insufficiently defined. This study characterizes inflammatory, endothelial, coagulation, and fibrinolytic trajectories following IL-6 receptor blockade in critically ill COVID-19 patients. Methods: In this prospective, exploratory multicenter case series (ClinicalTrials.gov NCT05218369), 15 ICU patients with PCR- or antigen-confirmed COVID-19 received tocilizumab per protocol. Serial sampling at five timepoints (T0–T4) included routine laboratories, comprehensive viscoelastic hemostatic assays (ClotPro^®), and ELISA-based endothelial and fibrinolytic biomarkers. Analyses were primarily descriptive, emphasizing temporal patterns through boxplots; paired Wilcoxon tests with FDR correction contextualized within-patient changes. Results: Patients exhibited marked inflammation, hyperfibrinogenemia, endothelial activation, and delayed fibrinolysis at baseline. IL-6 blockade induced rapid suppression of CRP and PCT, progressive declines in fibrinogen, and modest platelet increases. In contrast, vWF antigen and activity further increased, indicating persistent endothelial dysfunction. Viscoelastic testing showed preserved thrombin generation and sustained high clot firmness, while biochemical markers (rising PAI-1, modest PAP increase, and progressively increasing D-dimer) and VHA indices suggested ongoing antifibrinolytic activity despite resolution of systemic inflammation. Conclusions: IL-6 antagonism was associated with rapid attenuation of systemic inflammation but was not accompanied by normalization of endothelial activation or fibrinolytic resistance. The observed hemostatic profile was consistent with attenuation of inflammation-associated coagulation features, while endothelial and prothrombotic alterations appeared to persist during follow-up, warranting further investigation in larger controlled studies. Full article

Background/Objectives: High-quality bowel preparation is essential for the diagnostic accuracy of colonoscopy, the gold standard for colorectal cancer screening. In our study, we aimed to compare the efficacy and tolerability of three bowel preparation regimens—Moviprep with Donat Mg, Plenvu, and Plenvu with Donat Mg—commonly used in clinical practice in Slovenia. Methods: This was a randomized, multicenter, blinded clinical trial conducted across three Slovenian gastroenterology centers. A total of 300 consecutive adult patients undergoing elective colonoscopy were randomly assigned to one of the three bowel preparation groups. Bowel cleanliness was evaluated using the Boston Bowel Preparation Scale, and lesion detection was assessed using polyp detection rate (PDR) and adenoma detection rate (ADR). Patients also completed a questionnaire assessing adverse effects, overall tolerability, and willingness to repeat the same regimen. Statistical analyses included ANOVA, chi-square, Kruskal–Wallis, and t-tests. Results: Of the 300 patients included in the final analysis, 94 received Moviprep with Donat Mg, 96 received Plenvu, and 110 received Plenvu with Donat Mg. The mean age of participants was 58.4 ± 15.6 years; 158 patients (52.7%) were male and 142 (47.3%) were female. All three regimens achieved high bowel preparation adequacy (≥95%), with no statistically significant differences in total BBPS scores, PDR, or ADR. Adverse effects were mild and comparable between groups, with thirst and bloating being the most frequently reported symptoms. Patient satisfaction and willingness to repeat the preparation were high across all regimens, with no significant differences. Conclusions: Moviprep with Donat Mg, Plenvu, and Plenvu with Donat Mg are all effective, safe, and well-tolerated bowel preparation regimens. All regimens exceeded ESGE minimum quality standards. While the findings suggest that each regimen is suitable for routine use, the study was not powered to establish equivalence, and regimen selection should therefore continue to consider individual patient characteristics, preferences, and clinical judgment. Full article

Background: Large positive responses to placebo are common in clinical trials and pose a major challenge when evaluating different treatments, including new foods. Standard between-group comparisons may fail to detect true effects when placebo improvements are significant. We aimed to demonstrate how a simple dose–response correlation method can help differentiate genuine positive responses from those experienced with placebo through secondary analysis of a randomized controlled clinical trial of powdered Rosa-canina fruits. Methods: Data were reanalyzed from a multicenter, double-blind, randomized, placebo-controlled trial (N = 120; ClinicalTrials.gov NCT01459939) evaluating the effects of standardized Rosa-canina powder in hip and knee osteoarthritis (OA). Participants received fixed doses, leading to variability in mg/kg exposure due to different body weights. Pearson correlations between dose/kg and changes in WOMAC pain and function at 6 and 12 weeks were calculated separately for the active and placebo groups. Standard between-group comparisons were also performed. Results: Both groups showed significant improvement, over 50%, with no statistically significant differences between them in WOMAC pain or function. However, only the active group, which received a food supplement, exhibited a consistent negative correlation between body weight and symptom improvement at 6 and 12 weeks, suggesting greater benefit with higher dose per kilogram of body weight. No dose–response relationship was observed in the placebo recipients. Therefore, weight-stratified plots revealed an exposure–response gradient in the active group. Conclusions: Dose–response correlation analysis uncovered positive effects of Rosa-canina as a nutrient that were not detectable through standard between-group comparisons. This is consistent with findings from earlier rose-hip research. This low-cost, easy-to-implement method may help distinguish active effects from placebo responses in trials with large nonspecific improvements. Incorporating such analyses could improve the identification of nutrients containing biologically active preparations and support dose selection in future clinical research. Full article

This study evaluated the clinical bactericidal efficacy and safety of a novel chlorine dioxide teat disinfectant compared to a traditional iodine glycerin disinfectant in dairy cows. The randomized controlled trial included long-term natural exposure (100 cows) and teat surface disinfection (40 cows) experiments. Key metrics assessed were somatic cell count (SCC), teat skin health (dryness, roughness, hyperkeratosis), and bacterial reduction rates against Staphylococcus aureus, Escherichia coli, and Streptococcus spp. Results demonstrated that the chlorine dioxide teat disinfectant achieved comparable to iodine glycerin disinfectant in controlling the rate of SCC exceeding the threhold (3.57% vs. 4.50% at day 10; p > 0.05), teat skin dryness, end roughness, and hyperkeratosis severity showed no significant differences over time or between iodine glycerin (control) and chlorine dioxide teat disinfectant groups (all p > 0.05). Notably, quantitative bacteriological assessment revealed significantly higher log₁₀ reduction values for chlorine dioxide teat disinfectant (2.14) versus iodine glycerin controls (1.93; p < 0.05). Microbiological evaluation further demonstrated complete pathogen eradication (100.00%) by chlorine dioxide across all isolates (S. aureus, E. coli, Streptococcus spp.), whereas iodine glycerin achieved 99.84–100.00% bactericidal rates. The findings suggest that chlorine dioxide teat disinfectant is a sustainable and effective alternative to iodine glycerin disinfectant, offering robust antimicrobial activity, improved teat condition, and reduced residue concerns. Further multicenter studies are warranted to validate these outcomes under diverse herd management conditions. Full article

Background: The management of pediatric inflammatory bowel disease (PIBD) has evolved significantly over the past two decades, transitioning from corticosteroids and immunomodulators to biologic and small-molecule therapies. These advances have aimed not only to control inflammation but also to promote mucosal healing, improve growth, and enhance long-term quality of life. Objectives: This narrative review summarizes current evidence on the efficacy, safety, and clinical applications of biologic and novel small-molecule therapies in PIBD, highlighting emerging trends in personalized and precision-based management. Methods: A literature search was performed across PubMed, Embase, and the Cochrane Library, focusing on studies published within the last five years. Additional data were retrieved from key guidelines and position papers issued by ECCO–ESPGHAN, SIGENP, the FDA, and the EMA. Results: Anti–tumor necrosis factor (TNF) agents such as infliximab and adalimumab remain first-line biologics with proven efficacy in remission induction and maintenance. Newer biologics—vedolizumab, ustekinumab, risankizumab, and mirikizumab—offer alternatives for anti-TNF-refractory cases, showing encouraging short-term results and favorable safety profiles. Although many are approved only for adults with limited pediatric evidence, emerging small molecules—including Janus kinase (JAK) inhibitors (tofacitinib, upadacitinib) and sphingosine-1-phosphate (S1P) modulators (etrasimod)—provide oral, rapidly acting, and non-immunogenic treatment options for refractory disease. Furthermore, the gut microbiome is increasingly recognized as an emerging therapeutic target in PIBD, with growing evidence that host–microbiome interactions can influence both the efficacy and safety of biologics and small-molecule therapies. Conclusions: While biologics and small molecules have transformed PIBD management, challenges remain, including high treatment costs, limited pediatric trial data, and variable access worldwide. Future directions include multicenter pediatric studies, integration of pharmacogenomics, and biomarker-guided precision medicine to optimize early, individualized treatment and improve long-term outcomes. Full article

Background: Burns represent a public health problem because they generate both physical and psychological damage, especially in the child and adolescent population, and high costs, especially due to the management of scars. Advances in burn care have improved survival and quality of life for this population. New clinical trials have been conducted on the benefits of negative pressure wound therapy (NPWT), showing that it improves the healing of burns and the appearance of scars. Therefore, this study aims to analyze the efficacy of NPWT both alone and as an adjunct to conventional dressings in pediatric and adolescent patients compared with conventional treatments. Methodology: A systematic search was carried out between December 2023 and the last quarter of 2025 in databases such as PubMed, Scopus, CINAHL, and the Cochrane Library. This meta-analysis was performed following the PRISMA statement (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) and was registered in PROSPERO with registration number CRD42024597293. The risk of bias 2 (RoB2) tool was used to assess the risk of bias in the studies. Quantitative meta-analyses using random-model effects were performed only for variables with sufficient comparable data among studies. For other outcomes, where meta-analysis was not feasible due to lack of comparable data or control groups, results were synthesized qualitatively. Results: A total of seven articles (three clinical trials and four retrospective studies), in which a total of 323 subjects participated, were included. The main results demonstrate the efficacy of NPWT, as it decreases the re-epithelialization time, improves the appearance of scars (MD = −1.25 (95% CI between −1.80 and −0.70)), reduces the probability of skin grafts (OR = 0.17 (95% CI between 0.06 and 0.46)), and therefore, as there is less need for surgery and fewer dressing changes, reduces costs. Conclusions: NPWT offers significant clinical benefits in the treatment of burns in children and adolescents. Although a meta-analysis could not be performed due to the lack of a control group in some studies, studies with larger samples and multicenter designs will be necessary to better assess the relevant clinical outcomes. However, the results of this study show that NPWT is effective in treating burns in children and adolescents and that its use in clinical practice may represent a promising adjunctive therapy. Full article

Introduction: Immune evasion through inhibition of effector T cells is a key survival mechanism of lymphoma cells. We hypothesized that reinstating effector T cell activity through concurrent inhibition of the PD1/PD-L1 axis and of Treg activity will result in a synergistic anti-tumor effect with an acceptable toxicity profile. Methods: Phase I multi-institutional NCI-ETCTN trial aimed to evaluate the safety and tolerability of the combination of mogamulizumab and pembrolizumab in relapsed or refractory non-Hodgkin lymphoma. The study used a 3 + 3 design. Treatment consisted of mogamulizumab 1 mg/kg on days 1, 8, and 15 of cycle 1, followed by 1.5 mg/kg on day 1 of each subsequent 21-day cycle in combination with pembrolizumab 200 mg on day 1 of each cycle. A de-escalation level was defined as a 50% reduction in the dose of mogamulizumab (registered in clinicaltrials.gov NCT03309878). Results: The study was discontinued early, after treating seven patients (two angioimmunoblastic T cell lymphoma, four transformed follicular lymphoma, and one diffuse large B cell lymphoma of germinal center subtype) for concerns of futility and non-tolerability. Only two patients completed the first two cycles of treatment. Three patients presented with an early progression and three withdrew consent in the setting of general deterioration with clinically suspected progression. All six patients expired shortly after withdrawal from the study. The remaining patient experienced stress cardiomyopathy during the third cycle and was taken off the study. Discussion: In striking difference to the observation in solid malignancies, the combination of mogamulizumab with pembrolizumab was associated with low tolerability and suspected hyper-progression in patients with lymphoma. Full article

Hereditary ataxias are a heterogeneous group of disorders with overlapping clinical presentations but diverse genetic and molecular etiologies. Biomarkers are increasingly essential to improve diagnosis, refine prognosis, and accelerate the development of targeted therapies. Following PRISMA-ScR guidelines, we conducted a scoping review of PubMed and complementary sources (2010–2025) to map and describe the current landscape of genetic, imaging, fluid, electrophysiological, and digital biomarkers across the most prevalent hereditary ataxias, including SCA1, SCA2, SCA3, SCA6, SCA7, SCA17, SCA27B, dentatorubral–pallidoluysian atrophy (DRPLA), Friedreich’s ataxia (FRDA), RFC1-related ataxia (CANVAS), SPG7, and fragile X-associated tremor/ataxia syndrome (FXTAS). Eligible evidence encompassed observational cohorts, clinical trials, case series, and case reports providing primary biomarker data, with the objective of characterizing evidence breadth and identifying knowledge gaps rather than assessing comparative effectiveness. Across modalities, converging evidence highlights subtype-specific biomarker signatures. MRI volumetry, DTI, and FDG-PET map characteristic neurodegeneration patterns. Fluid biomarkers such as neurofilament light chain are informative across several SCAs and FRDA, while frataxin levels constitute robust endpoints in FRDA trials. Pathology-specific biomarkers such as ataxin-3 are advancing as tools for target engagement and may generalize to future gene-lowering strategies. Electrophysiological and oculographic measures show sensitivity for early disease detection, and wearable technologies are emerging as scalable tools for longitudinal monitoring. This scoping review synthesizes the heterogeneous evidence on hereditary ataxia biomarkers, highlighting multimodal frameworks that link molecular mechanisms with clinical endpoints. Mapping current approaches also reveals substantial variability and gaps across diseases and modalities, underscoring the need for harmonized validation in international multicenter cohorts and systematic integration into future clinical trials to advance precision medicine in hereditary ataxias. Full article

Background: Fibromyalgia syndrome (FMS) and post-traumatic stress disorder (PTSD) may co-occur and are associated with increased symptom burden, functional impairment, and reduced quality of life. Accumulating evidence suggests shared neurobiological mechanisms. Trauma-focused interventions targeting maladaptive memory processes may therefore represent a relevant therapeutic approach in this population. Objective: To evaluate the feasibility, tolerability, and preliminary clinical associations of a brief reconsolidation-based therapy in women with comorbid FMS and PTSD. Methods: This multicenter pilot study included adult women diagnosed with FMS and PTSD who underwent six sessions of reconsolidation therapy combining traumatic memory reactivation with propranolol administration. Clinical outcomes were assessed at baseline and at 3-month follow-up using the Fibromyalgia Impact Questionnaire (FIQ), the Impact of Event Scale–Revised (IES-R), the Montgomery–Åsberg Depression Rating Scale (MADRS), the Beck Depression Inventory (BDI), the Rosenberg Self-Esteem Scale (RSES), and the SF-36. Changes over time were analyzed using paired statistical tests and linear mixed-effects models. Results: Fourteen participants completed the intervention and follow-up assessments. The intervention was feasible and well tolerated. Changes over time were observed in fibromyalgia-related quality of life (FIQ scores), PTSD symptom severity (IES-R), and depressive symptoms (MADRS, BDI), as well as in selected SF-36 domains, including vitality, social functioning, and mental health. A progressive decrease in IES-R scores was observed across treatment sessions. Conclusions: This pilot study suggests that reconsolidation-based therapy is feasible in women with comorbid FMS and PTSD and was associated with changes in PTSD symptoms and fibromyalgia-related functional impact. Given the exploratory design and absence of a control group, these findings should be interpreted cautiously and warrant confirmation in larger, controlled trials. Full article

Background/Objectives: Fibroepithelial tumors (FETs) of the breast, including fibroadenomas (FAs) and phyllodes tumors (PTs), are among the most common breast masses encountered by breast radiologists and pathologists. Differentiating FAs from benign or borderline PTs can be challenging, especially on core biopsy specimens where sampling limitations obscure key histologic features. Although imaging techniques provide useful diagnostic context, their predictive accuracy for pathologic classification remains limited. Methods: We conducted a single-institution pilot study to assess whether tumor growth rate (TGR) derived from serial imaging could serve as a noninvasive correlate of histopathologic outcomes in FETs. Thirty-two patients with serial imaging and subsequent surgical excision (January 2020–May 2025) were analyzed. TGR, expressed as percentage volume increase per month, was calculated from diameter-based volumetrics. Results: The cohort included conventional FA (n = 10), cellular FA (n = 4), benign PT (n = 8), borderline PT (n = 6), and malignant PT (n = 4). Malignant PTs demonstrated significantly higher median TGRs (180.4%/month) and shorter imaging intervals (1.1 months) compared with other groups (p = 0.0357 and p = 0.005, respectively). These large effect-size differences suggest clinically meaningful growth dynamics. Conclusions: As a pilot, this study establishes foundational variance and effect-size estimates for powering a multicenter trial. If validated, TGR may provide an objective, noninvasive metric to enhance preoperative risk stratification and guide management of breast FETs. Full article