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Will (Radio)Theranostics Hold Up in the 21st Century—and Why?
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Will (Radio)Theranostics Hold Up in the 21st Century—and Why?

A topical collection in Pharmaceuticals (ISSN 1424-8247). This collection belongs to the section "Radiopharmaceutical Sciences".

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Editors

Prof. Dr. Klaus Kopka

E-Mail Website
Collection Editor
Helmholtz-Zentrum Dresden-Rossendorf (HZDR), Institute of Radiopharmaceutical Cancer Research, 01328 Dresden, Germany
Interests: radiopharmaceutical drug development; radiopharmaceutical sciences; medicinal radiochemistry; radionuclide theranostics; targeted endoradiotherapy; noninvasive molecular imaging; PET; SPECT
Special Issues, Collections and Topics in MDPI journals
Dr. Irina Velikyan

E-Mail Website
Collection Editor
Department of Surgical Science, Uppsala University, 751 85 Uppsala, Sweden
Interests: nuclear medicine; radiochemistry; positron emission tomography; molecular imaging; radiopharmaceutical sciences; cancer; diabetes; fibrosis; drug development; inflammation
Special Issues, Collections and Topics in MDPI journals

Topical Collection Information

Dear Colleagues,

Modern theranostics is rapidly evolving and encompasses a variety of approaches that merge precision diagnostics with targeted therapies. This includes (radio)theranostics, which combines radionuclide imaging with radiotherapy or other therapeutic modalities. The therapies incorporate surgical interventions, pharmacological treatments, as well as exo- and endoradiotherapy.

As we stand at the intersection of diagnostic innovation and therapeutic advancement, the paradigm of (radio)theranostics is reshaping personalized medicine and challenging established clinical workflows. The field has experienced substantial growth over the past decade, driven by remarkable success in academically driven clinical studies targeting somatostatin receptors and prostate-specific membrane antigens. This progress has spurred prospective clinical trials and subsequently the commercialization of corresponding radiopharmaceuticals and the broader adoption of radiotheranostic technology. However, the future development of (radio)theranostics will be shaped by a complex interplay of factors, both advancing and challenging its continued evolution.

On one hand, these hybrid approaches are opening new avenues for individualized treatment, leveraging cutting-edge imaging technologies to precisely localize disease and tailor therapy to each patient’s unique profile. This convergence promises improved outcomes through more accurate diagnoses and optimized treatment strategies, reducing side effects and enhancing overall efficacy.

On the other hand, significant hurdles remain. The integration of diverse diagnostic modalities with multiple treatment forms raises complex issues related to technological compatibility, regulatory oversight, and economic feasibility. As the field broadens beyond traditional radionuclide applications, it demands robust infrastructure, interdisciplinary collaboration, and innovative research to fully realize its potential.

We invite authors to contribute their insights, critical analyses, and innovative perspectives on the future of modern theranostics. Whether your focus is on the continued development of radiopharmaceuticals and radionuclide production, the technical and technological advancements, clinical implications, or the regulatory and socio-economic challenges of integrating precision diagnostics with various therapeutic modalities, your contribution will help illuminate the multifaceted dynamics that will determine whether this paradigm can endure the tests of the 21st century.

Prof. Dr. Klaus Kopka
Dr. Irina Velikyan
Collection Editors

Manuscript Submission Information

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Keywords

  • (radio)theranostics
  • precision imaging
  • molecular imaging
  • targeted (radio)therapies
  • personalized medicine
  • diagnostic innovation
  • economic feasibility
  • regulatory challenges
  • interdisciplinary collaboration
  • clinical adoption
  • technological advancements
  • socio-economic impact
  • healthcare infrastructure
  • diagnostic and therapeutic radionuclide production
  • radiopharmaceutical development
  • positron emission tomography
  • single photon emission tomography
  • dosimetry

Published Papers (2 papers)

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2025

17 pages, 501 KB  
Article
How Regulation 536/2014 Is Changing Academic Research with Therapeutic Radiopharmaceuticals: A Local Experience
by Valentina Di Iorio, Stefano Boschi, Erika Brugugnoli, Maddalena Sansovini, Federica Matteucci, Carla Masini and Manuela Monti
Pharmaceuticals 2025, 18(11), 1709; https://doi.org/10.3390/ph18111709 - 11 Nov 2025
Viewed by 164
Abstract
Background/Objectives: This report examines the future of academic studies involving investigational therapeutic radiopharmaceuticals within the framework of Regulation (EU) No. 536/2014. It discusses the impact of Good Manufacturing Practice (GMP) requirements (EudraLex-Volume 4-Good Manufacturing Practice guidelines) on the development of radiopharmaceuticals, based [...] Read more.
Background/Objectives: This report examines the future of academic studies involving investigational therapeutic radiopharmaceuticals within the framework of Regulation (EU) No. 536/2014. It discusses the impact of Good Manufacturing Practice (GMP) requirements (EudraLex-Volume 4-Good Manufacturing Practice guidelines) on the development of radiopharmaceuticals, based on local experience and analysis. Methods: The report was drafted by analysing multiple factors, including the European regulatory context regarding EMA guidance for investigational medicinal products (IMPs) and GMP requirements for radiopharmaceuticals, as well as position papers from various scientific associations. An analysis of all the relevant changes was conducted by a multidisciplinary team comprising radiopharmacists, nuclear medicine physicians, research experts and technology transfer specialists. They conducted a literature review to examine the clinical implications of the regulatory change and assess the impact of Regulation 536/2014 on academic clinical trials. Results: IRST has around 20 years’ experience in radiopharmaceutical clinical research. From 2008 to 2025, it conducted 16 clinical trials with radiopharmaceuticals under the Directive, and it is currently promoting five studies under the Regulation. During this time, more than 1000 patients were enrolled. The transition was based on staff training in quality documentation, the constitution of a contract research organisation (CRO) to ensure data quality and transfer, careful budget planning, the evaluation of innovative business models and the role of a Contract Development and Manufacturing Organization (CDMO). These integrated approaches enabled IRST to transform regulatory constraints into an opportunity to enhance its organisational model, improve data reliability, and strengthen its position as a centre of excellence for radiopharmaceutical research and production. Conclusions: The implementation of EU Regulation 536/2014 has significantly impacted academic research centres, especially those specialising in radiopharmaceuticals. Adhering to Good Manufacturing Practice (GMP) for therapeutic radiopharmaceuticals requires a considerable investment in infrastructure and personnel. However, the regulation also presents opportunities for research centres to enhance their capabilities. Meeting GMP standards can help institutions improve the quality and reliability of their clinical trials, potentially making them more competitive in the international research arena. Full article
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22 pages, 1723 KB  
Review
Clinical Experience with Targeted Alpha-Emitter Peptide Receptor Radionuclide Therapy (α-PRRT) for Somatostatin Receptor-Positive Neuroendocrine Tumors
by Hannes Leupe, Merel Cauwenbergh, Frederik Cleeren, Jeroen Dekervel, Chris Verslype and Christophe M. Deroose
Pharmaceuticals 2025, 18(11), 1608; https://doi.org/10.3390/ph18111608 - 24 Oct 2025
Viewed by 867
Abstract
Background: α-emitting Peptide Receptor Radionuclide Therapy (α-PRRT) is emerging as a promising new generation of PRRT for neuroendocrine tumors (NETs), providing enhanced tumor cell cytotoxicity and reduced irradiation of adjacent healthy tissues due to its high linear energy transfer (LET) and short particle [...] Read more.
Background: α-emitting Peptide Receptor Radionuclide Therapy (α-PRRT) is emerging as a promising new generation of PRRT for neuroendocrine tumors (NETs), providing enhanced tumor cell cytotoxicity and reduced irradiation of adjacent healthy tissues due to its high linear energy transfer (LET) and short particle range. This review summarizes available clinical evidence on α-PRRT using different α-emitting isotopes, including actinium-225, lead-212, and bismuth-213, in somatostatin receptor (SSTR)-positive NETs. Methods: A comprehensive literature search was conducted across PubMed, Embase, Cochrane Library, Scopus, Web of Science, and ClinicalTrials.gov, as well as major oncology congress abstracts (ENETS, ESMO, ASCO). Eligible studies included clinical trials evaluating α-PRRT in patients with advanced SSTR-positive NETs, reporting therapeutic response and adverse events. The primary endpoint was the objective response rate (ORR); secondary endpoints included disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety. Results: Seven studies encompassing 150 patients were included. Treatment with [225Ac]Ac-DOTATATE yielded a pooled ORR of 50% and a DCR of 81.3% across 121 evaluable patients. The best responses were observed in patients who had previously responded to β-PRRT (ORR 70.4%, DCR 96.3%), while one-third of β-PRRT–refractory patients achieved partial or complete responses. [212Pb]Pb-DOTAMTATE demonstrated an ORR of 56.8% and DCR of 100% in preliminary phase II results, though dysphagia was noted in 34% of patients. [213Bi]Bi-DOTATOC and [212Pb]Pb-VMT-α-NET studies also showed promising disease control with minimal grade ≥ 3 hematologic or renal toxicities. Across all studies, α-PRRT was well tolerated, with predominantly low-grade hematologic adverse events and no significant hepatic or renal toxicity. Conclusions: Clinical data to date indicate that α-PRRT offers meaningful therapeutic benefit in patients with metastatic or treatment-refractory NETs, achieving favorable response rates with manageable toxicity. Early results support α-PRRT as a potential first- or second-line therapeutic option. Ongoing phase III trials will be critical to confirm its long-term safety, survival outcomes, and role in routine clinical practice. Full article
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