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Brain Sciences
Special Issues
Future of Clinical Trials in Surgical Neuro-Oncology
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Future of Clinical Trials in Surgical Neuro-Oncology

A special issue of Brain Sciences (ISSN 2076-3425). This special issue belongs to the section "Neuro-oncology".

Deadline for manuscript submissions: closed (31 December 2023) | Viewed by 14841

Special Issue Editors

Dr. Sauson Soldozy

E-Mail Website
Guest Editor
Department of Neurological Surgery, University of Miami, Miami, FL 33136, USA
Interests: skull base; pituitary neoplasms; neuro-oncology; clinical trials; tumor; radiosurgery; endoscope; key-hole; immu-notherapy; virotherapy; tractography; connectomics
Dr. Ashish H. Shah

E-Mail Website
Guest Editor
Surgical Neurology Branch, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD 21201, USA
Interests: neuro-oncology; clinical trials; tumor; radiosurgery; endoscope; key-hole; immu-notherapy; virotherapy; tractography; connectomics
Dr. Ricardo J. Komotar

E-Mail Website
Guest Editor
Department of Neurological Surgery, University of Miami, Miami, FL 33146, USA
Interests: neuro-oncology; clinical trials; tumor; radiosurgery; endoscope; key-hole; immu-notherapy; virotherapy; tractography; connectomics
Dr. Michael E. Ivan

E-Mail Website
Guest Editor
Department of Neurological Surgery, University of Miami, Miami, FL 33146, USA
Interests: skull base; pituitary neoplasms; neuro-oncology; clinical trials; tumor; radiosurgery; endoscope; key-hole; immu-notherapy; virotherapy; tractography; connectomics

Special Issue Information

Dear Colleagues,

Surgical neuro-oncology encompasses the entire spectrum of neoplastic processes encountered by neurosurgeons, including benign, neoplastic, metastatic, and spinal tumors. The 21st century has marked a new era of surgical neuro-oncology, and it can be characterized by the marriage between new microsurgical techniques, cutting-edge technologies, modern imaging modalities, and translational scientific breakthroughs. Surgical advances include the introduction of minimally invasive key-hole surgery, endoscopic approaches, awake surgery, fluorescence guided resection, stereotactic radiosurgery, and laser interstitial thermal therapy. High-definition white matter tractography and the emergence of connectomics in conjunction with artificial intelligence have revolutionized how we visualize and localize pathology and neuroanatomical derangements. By pairing this with the continuous basic scientific innovations taking place including immune cell therapy, gene therapy, and oncolytic virotherapy, the field of surgical neuro-oncology is developing at an exponential pace. Through clinical trials, we are able to translate ideas into action for the betterment of our patients afflicted with these life changing ailments. The aim of this Special Issue is to solicit articles addressing the future of clinical trials in surgical neuro-oncology. We seek articles describing cutting-edge and novel techniques, employing new devices or imaging technology, new basic science advances, suggestions for areas of future research, and results of recent trials and what they mean for the field of surgical neuro-oncology moving forward. We welcome editorials, commentaries, reviews, proof-of concept studies, surgical anatomical studies, technical reports, and original clinical or basic science articles.

Dr. Sauson Soldozy 
Dr. Ashish H. Shah 
Dr. Ricardo J. Komotar 
Dr. Michael E. Ivan 
Guest Editors

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Brain Sciences is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2200 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • neuro-oncology
  • clinical trials
  • tumor
  • radiosurgery
  • endoscope
  • key-hole
  • immu-notherapy
  • virotherapy
  • tractography
  • connectomics

Published Papers (5 papers)

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Research

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15 pages, 13727 KiB  
Article
The NXDC-MEN-301 Study on 5-ALA for Meningiomas Surgery: An Innovative Study Design for the Assessing the Benefit of Intra-Operative Fluorescence Imaging
by Walter Stummer, Markus Holling, Bernard R. Bendok, Michael A. Vogelbaum, Ashley Cox, Sara L. Renfrow, Georg Widhalm, Alan Ezrin, Salvatore DeSena, Murray L. Sackman and Joseph W. Wyse
Brain Sci. 2022, 12(8), 1044; https://doi.org/10.3390/brainsci12081044 - 6 Aug 2022
Cited by 5 | Viewed by 2246
Abstract
Background: 5-aminolevulinic acid (5-ALA; GleolanTM, NX Development Corps., Lexington, USA) is approved for fluorescence-guided resections of suspected malignant gliomas. Experience has demonstrated that meningiomas also show fluorescence, which may be a useful surgical adjunct. We present an innovative design for a [...] Read more.
Background: 5-aminolevulinic acid (5-ALA; GleolanTM, NX Development Corps., Lexington, USA) is approved for fluorescence-guided resections of suspected malignant gliomas. Experience has demonstrated that meningiomas also show fluorescence, which may be a useful surgical adjunct. We present an innovative design for a multi-center, prospective study to determine the clinical safety and potential benefit of fluorescence-guided resection of meningiomas with utmost bias reduction. Methods: All patients with suspected meningioma (all grades) receive GleolanTM 20 mg/kg 2–4 h prior to surgery supported by fluorescence excitation from a blue light source (Blue400, Zeiss Meditech, Oberkochen, Germany; FL400, Leica Microsystems, Heerbrugg, Switzerland). Surgeons are asked whether a residual tumor can be observed to fluoresce under blue light (BL) after the tumor is no longer recognizable using conventional illumination at the end of surgery. In addition, when faced with tissues of uncertain tissue type (so-called “indeterminate” tissue), this study records how often surgeons make a correct decision based on fluorescence and how this influences surgical strategy. The primary endpoint is the percentage of patients in whom one of these two benefits are observed. Other endpoints include the diagnostic accuracy of fluorescence compared to white light (WL) versus correlative histology. For bias reduction, pertinent data are derived from surgical videos reviewed by independent reviewers blinded to surgeons’ assessments of tissue type and fluorescence status. Data will be included from approximately 100 study participants completing the study at approximately 15 centers in the United States, Germany, and Austria. Results: As of May 2022, 88 patients have completed the study. No adverse safety signal has been detected. Conclusions: Preliminary data confirm the feasibility of our study design. Accrual is targeted for completion in the third quarter of 2022. Full article
(This article belongs to the Special Issue Future of Clinical Trials in Surgical Neuro-Oncology)
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Review

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14 pages, 480 KiB  
Review
Single-Cell RNA Sequencing of Cerebrospinal Fluid as an Advanced Form of Liquid Biopsy for Neurological Disorders
by Anudeep Yekula, Jovanna Tracz, Jordina Rincon-Torroella, Tej Azad and Chetan Bettegowda
Brain Sci. 2022, 12(7), 812; https://doi.org/10.3390/brainsci12070812 - 22 Jun 2022
Cited by 6 | Viewed by 3402
Abstract
Diagnosis and longitudinal monitoring of neurological diseases are limited by the poor specificity and limited resolution of currently available techniques. Analysis of circulating cells in cerebrospinal fluid (CSF) has emerged as a promising strategy for the diagnosis, molecular characterization, and monitoring of neurological [...] Read more.
Diagnosis and longitudinal monitoring of neurological diseases are limited by the poor specificity and limited resolution of currently available techniques. Analysis of circulating cells in cerebrospinal fluid (CSF) has emerged as a promising strategy for the diagnosis, molecular characterization, and monitoring of neurological disease. In comparison to bulk sequencing analysis, single-cell sequencing studies can provide novel insights into rare cell populations and uncover heterogeneity in gene expression at a single-cell resolution, which has several implications for understanding disease pathology and treatment. Parallel development of standardized biofluid collection protocols, pre-processing strategies, reliable single-cell isolation strategies, downstream genomic analysis, and robust computational analysis is paramount for comprehensive single-cell sequencing analysis. Here we perform a comprehensive review of studies focusing on single-cell sequencing of cells in the CSF of patients with oncological or non-oncological diseases of the central nervous system. Full article
(This article belongs to the Special Issue Future of Clinical Trials in Surgical Neuro-Oncology)
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13 pages, 583 KiB  
Review
Neurosurgical Clinical Trials for Glioblastoma: Current and Future Directions
by Ashish H. Shah and John D. Heiss
Brain Sci. 2022, 12(6), 787; https://doi.org/10.3390/brainsci12060787 - 15 Jun 2022
Cited by 3 | Viewed by 2403
Abstract
The mainstays of glioblastoma treatment, maximal safe resection, radiotherapy preserving neurological function, and temozolomide (TMZ) chemotherapy have not changed for the past 17 years despite significant advances in the understanding of the genetics and molecular biology of glioblastoma. This review highlights the neurosurgical [...] Read more.
The mainstays of glioblastoma treatment, maximal safe resection, radiotherapy preserving neurological function, and temozolomide (TMZ) chemotherapy have not changed for the past 17 years despite significant advances in the understanding of the genetics and molecular biology of glioblastoma. This review highlights the neurosurgical foundation for glioblastoma therapy. Here, we review the neurosurgeon’s role in several new and clinically-approved treatments for glioblastoma. We describe delivery techniques such as blood–brain barrier disruption and convection-enhanced delivery (CED) that may be used to deliver therapeutic agents to tumor tissue in higher concentrations than oral or intravenous delivery. We mention pivotal clinical trials of immunotherapy for glioblastoma and explain their outcomes. Finally, we take a glimpse at ongoing clinical trials and promising translational studies to predict ways that new therapies may improve the prognosis of patients with glioblastoma. Full article
(This article belongs to the Special Issue Future of Clinical Trials in Surgical Neuro-Oncology)
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Other

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15 pages, 66628 KiB  
Technical Note
Adaptive Hybrid Surgery Experiences in Benign Skull Base Tumors
by Jenny Christine Kienzler and Javier Fandino
Brain Sci. 2022, 12(10), 1326; https://doi.org/10.3390/brainsci12101326 - 30 Sep 2022
Viewed by 1189
Abstract
Background: The treatment of benign skull base tumors remains challenging. These tumors are often located in close relationship to critical structures. Therefore, radical resection of these tumors can be associated with high morbidity. Multimodal treatment concepts, including controlled partial tumor resection followed by [...] Read more.
Background: The treatment of benign skull base tumors remains challenging. These tumors are often located in close relationship to critical structures. Therefore, radical resection of these tumors can be associated with high morbidity. Multimodal treatment concepts, including controlled partial tumor resection followed by radiosurgery, should be considered. Methods: Adaptive hybrid surgery analysis (AHSA) is an intraoperative tool that has been introduced for the automatic assessment of tumor properties, and virtual real-time radiosurgical treatment simulation and continuous feasibility analysis of adjuvant radiosurgery. The AHSA method (Brainlab®, Munich, Germany) was applied to five patients who underwent partial resection of a benign skull base tumor. Tumor volumetry was obtained on pre- and postoperative MR scans. Organs at risk were, preoperative, automatically delineated with atlas mapping software (Elements® Segmentation Cranial), and adaptations were made if necessary. Results: Five patients with benign skull base lesions underwent planned partial tumor resection in a multimodal therapeutic surgery followed by radiosurgery. The preoperative tumor volumes ranged between 8.52 and 25.2 cm3. The intraoperative residual tumor volume measured with the AHSA® software ranged between 2.13–12.17 cm3 (25–52% of the preoperative tumor volume). The intraoperative automatic AHSA plans of the remaining tumor volume suggested, in all five patients, that safe hypofractionated radiation was feasible. Patients were followed for 69.6 ± 1.04 months, and no complications occurred after the patients were treated with radiation. Conclusions: Intraoperative SRS planning based on volumetric assessments during resection of skull base tumors using AHSA® is feasible and safe. The AHSA method allows the neurosurgeon to continuously evaluate the feasibility of adjuvant radiosurgery while planning and performing a surgical resection. This method supports the treatment strategy of a complementary approach during surgical resection of complex skull base tumors and might contribute to preventing surgical and radiosurgical complications. Full article
(This article belongs to the Special Issue Future of Clinical Trials in Surgical Neuro-Oncology)
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7 pages, 1404 KiB  
Technical Note
Conservative Management of Post-Operative Cerebrospinal Fluid Leak following Skull Base Surgery: A Pilot Study
by Aria M. Jamshidi, Ashish Shah, Daniel G. Eichberg, Ricardo J. Komotar and Michael Ivan
Brain Sci. 2022, 12(2), 152; https://doi.org/10.3390/brainsci12020152 - 24 Jan 2022
Cited by 3 | Viewed by 4391
Abstract
Background/aims: Iatrogenic CSF leaks after endoscopic endonasal transsphenoidal surgery remain a challenging entity to manage, typically treated with CSF diversion via lumbar drainage. Objective: To assess the safety and efficacy of high-volume lumbar puncture (LP) and acetazolamide therapy to manage iatrogenic CSF leaks. [...] Read more.
Background/aims: Iatrogenic CSF leaks after endoscopic endonasal transsphenoidal surgery remain a challenging entity to manage, typically treated with CSF diversion via lumbar drainage. Objective: To assess the safety and efficacy of high-volume lumbar puncture (LP) and acetazolamide therapy to manage iatrogenic CSF leaks. Methods: We performed a prospective pilot study of four patients who developed iatrogenic postoperative CSF leaks after transsphenoidal surgery and analyzed their response to treatment with concomitant high-volume lumbar puncture followed by acetazolamide therapy for 10 days. Data collected included demographics, intra-operative findings, including methodology of skull base repair and type of CSF leak, time to presentation with CSF leak, complications associated with high-volume LP and acetazolamide treatment, and length of follow-up. Results: Mean patient age was 44.28 years, with an average BMI of 27.4. Mean time from surgery to onset of CSF leak was 7.71 days. All four patients had resolution of their CSF leak at two- and four-week follow-up. Mean overall follow-up time was 179 days, with a 100% CSF leak cure rate at the last clinic visit. No patient suffered perioperative complications or complications secondary to treatment. Conclusion: Although our pilot case series is small, we demonstrate that a high-volume LP, followed by acetazolamide therapy for 10 days, can be considered in the management of post-operative CSF leaks. Full article
(This article belongs to the Special Issue Future of Clinical Trials in Surgical Neuro-Oncology)
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