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Past, Present and Future Radiotracer Techniques: Radiopharmaceuticals in Cancer Theranostics
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Past, Present and Future Radiotracer Techniques: Radiopharmaceuticals in Cancer Theranostics

A special issue of Pharmaceuticals (ISSN 1424-8247). This special issue belongs to the section "Radiopharmaceutical Sciences".

Deadline for manuscript submissions: 28 February 2025 | Viewed by 12972

Special Issue Editors

Dr. Ute Hennrich

E-Mail Website
Guest Editor
Service Unit Radiopharmaceuticals and Pre-Clinical Studies, German Cancer Research Center (DKFZ), Im Neuenheimer Feld 223, 69120 Heidelberg, Germany.
Interests: radiopharmaceutical chemistry; GMP production; quality control; automated synthesis; positron emission tomography (PET); diagnostic tracers
Dr. Martina Benešová-Schäfer

E-Mail Website
Guest Editor
Research Group Molecular Biology of Systemic Radiotherapy, Research Program Imaging and Radiooncology, German Cancer Research Center (DKFZ), Im Neuenheimer Feld 223, 69120 Heidelberg, Germany
Interests: theranostic radioligands; targeted radionuclide therapies; targeted alpha therapies; combination therapies; molecular imaging; pharmaceutical radiochemistry; coordination and bioinorganic chemistry; radionuclide production and separation methods
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues, 

Following its tradition of publishing Special Issues on selected and highly interesting topics, the journal “Pharmaceuticals” is planning to launch a new Special Issue on the topic “Past, Present and Future Radiotracer Techniques: Radiopharmaceuticals in Cancer Theranostics”. 

More than five years ago, [177Lu]Lu-DOTA-TATE (Lutathera®) was approved by both the EMA and the FDA as the first radiopharmaceutical for Peptide Receptor Radionuclide Therapy (PRRT) of neuroendocrine tumors (NET) while joining its diagnostic counter-partner [68Ga]Ga-DOTA-TOC (SomaKit TOC®, TOCscan®). A further success story was represented by the approval of [177Lu]Lu-PSMA-617 (Pluvicto®) to various diagnostic counter-partners like [68Ga]Ga-PSMA-11 (Locametz®/Illuccix®) or [18F]DCFPyL (PYLARIFY®)  for the treatment of prostate cancer. Both radiotherapeutics are prime examples for the successful application of targeted radionuclide therapy (TRNT) in modern cancer management. 

However, the aforementioned theranostic pairs can only supply a limited number of cancer patients and, therefore, the development of new radiotracers and/or radiopharmaceuticals for various targets and cancer types is further ongoing. Such a developmental chain usually takes a couple of years and involves a variety of different steps from synthesis of the labeling precursor and reference compounds, optimization of radiolabeling and pre-clinical evaluations to the development of automated GMP compliant synthesis and quality control, first-in-human studies and various clinical trials. All these essential steps can be covered in the Special Issue. Areas of interest include, but are not limited to: 

  • Development and pre-clinical evaluation of diagnostic tracers and radiotherapeutic pharmaceuticals·       
  • Establishment and validation of GMP compliant synthesis and quality control·       
  • Translation into clinics: first-in-human studies, clinical trials

Please refer also to the list of keywords.

We cordially invite you to submit research as well as review articles to this Special Issue and look forward to reading your articles.

Dr. Ute Hennrich
Dr. Martina Benešová-Schäfer
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. Pharmaceuticals 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 2900 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

  • diagnostic radiotracers
  • therapeutic radiopharmaceuticals
  • theranostics
  • radiolabeling techniques
  • GMP compliance
  • automated synthesis and quality control
  • pre-clinical studies
  • translation into clinics and first-in-human studies
  • clinical trials
  • regulatory approval

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Published Papers (9 papers)

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Research

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14 pages, 1950 KiB  
Article
Fully Automated Production of (((S)-1-Carboxy-5-(6-([18F]fluoro)-2-methoxynicotinamido)pentyl)carbamoyl)-l-glutamic Acid ([18F]JK-PSMA-7)
by Philipp Krapf, Thomas Wicher, Boris D. Zlatopolskiy, Johannes Ermert and Bernd Neumaier
Pharmaceuticals 2025, 18(1), 119; https://doi.org/10.3390/ph18010119 - 17 Jan 2025
Viewed by 529
Abstract
Background: The radiotracer [18F]JK-PSMA-7, a prostate cancer imaging agent for positron emission tomography (PET), was previously synthesized by indirect radiofluorination using an 18F-labeled active ester as a prosthetic group, which had to be isolated and purified before it could be [...] Read more.
Background: The radiotracer [18F]JK-PSMA-7, a prostate cancer imaging agent for positron emission tomography (PET), was previously synthesized by indirect radiofluorination using an 18F-labeled active ester as a prosthetic group, which had to be isolated and purified before it could be linked to the pharmacologically active Lys-urea-Glu motif. Although this procedure could be automated on two-reactor modules like the GE TRACERLab FX2N (FXN) to afford the tracer in modest radiochemical yields (RCY) of 18–25%, it is unsuitable for cassette-based systems with a single reactor. Methods: To simplify implementation on an automated synthesis module, the radiosynthesis of [18F]JK-PSMA-7 was devised as a one-pot, two-step reaction. The new method is based on direct (“late-stage”) radiofluorination of an appropriate onium triflate precursor and subsequent deprotection with ortho-phosphoric acid. It was successfully established on the cassette-based Trasis AllInOne (AIO) module. Results: Overall, the new protocol enabled the production of [18F]JK-PSMA-7 in activity yields of 39 ± 4% (RCY = 58%) with an overall synthesis time of about 1 h. In a single production run with an initial activity of 36-43 GBq, 13-19 GBq of [18F]JK-PSMA-7 with a radiochemical purity of >99% was obtained. Conclusions: We have established a highly reliable, GMP-compliant process for the automated radiosynthesis of [18F]JK-PSMA-7 on the Trasis AllinOne (AIO) synthesizer, ensuring consistent and efficient production of this radioligand. Full article
(This article belongs to the Special Issue Past, Present and Future Radiotracer Techniques: Radiopharmaceuticals in Cancer Theranostics)
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24 pages, 2487 KiB  
Article
[68Ga]Ga-FAPI-46 PET/CT for Staging Suspected/Confirmed Lung Cancer: Results on the Surgical Cohort Within a Monocentric Prospective Trial
by Lucia Zanoni, Emilia Fortunati, Giulia Cuzzani, Claudio Malizia, Filippo Lodi, Veronica Serena Cabitza, Irene Brusa, Stefano Emiliani, Marta Assenza, Filippo Antonacci, Francesca Giunchi, Alessio Degiovanni, Marco Ferrari, Filippo Natali, Thomas Galasso, Gian Piero Bandelli, Simona Civollani, Piero Candoli, Antonietta D’Errico, Piergiorgio Solli, Stefano Fanti and Cristina Nanniadd Show full author list remove Hide full author list
Pharmaceuticals 2024, 17(11), 1468; https://doi.org/10.3390/ph17111468 - 1 Nov 2024
Cited by 1 | Viewed by 1175
Abstract
Background/Objectives. To evaluate T&N-staging diagnostic performance of [68Ga]Ga-FAPI-46 PET/CT (FAPI) in a suspected/confirmed lung cancer surgical cohort. Methods: Patients were enrolled in a prospective monocentric trial (EudraCT: 2021-006570-23) to perform FAPI, in addition to conventional-staging-flow-chart (including [18F]F-FDG PET/CT-FDG). For the current purpose, only [...] Read more.
Background/Objectives. To evaluate T&N-staging diagnostic performance of [68Ga]Ga-FAPI-46 PET/CT (FAPI) in a suspected/confirmed lung cancer surgical cohort. Methods: Patients were enrolled in a prospective monocentric trial (EudraCT: 2021-006570-23) to perform FAPI, in addition to conventional-staging-flow-chart (including [18F]F-FDG PET/CT-FDG). For the current purpose, only surgical patients were included. PET-semiquantitative parameters were measured for T&N: SUVmax, target-to-background-ratios (using mediastinal blood pool-MBP, liver-L and pulmonary-parenchyma-P). Visual and semiquantitative T&N PET/CT performances were analysed per patient and per region for both tracers, with surgical histopathology as standard-of-truth. Results: 63 FAPI scans were performed in 64 patients enrolled (26 May 2022–30 November 2023). A total of 50/63 patients underwent surgery and were included. Agreement (%) with histopathological-T&N-StagingAJCC8thEdition was slightly in favour of FAPI (T-66% vs. 58%, N-78% vs. 70%), increasing when T&N dichotomised (T-92% vs. 80%, N-78% vs. 72%). The performance of Visual-Criteria for T-per patient (n = 50) resulted higher FAPI than FDG. For N-per patient (n = 46), sensitivity and NPV were slightly lower with FAPI. Among 59 T-regions surgically examined, malignancy was excluded in 6/59 (10%). FAPI showed (vs. FDG): sensitivity 85% (vs. 72%), specificity 67% (vs. 50%), PPV 96% (vs. 93%), NPV 33% (vs. 17%), accuracy 83% (vs. 69%). Among 217 N-stations surgically assessed (overall 746 ln removed), only 15/217 (7%) resulted malignant; FAPI showed (vs. FDG): sensitivity 53% (vs. 60%), PPV 53% (vs. 26%), NPV 97% (vs. 97%), and significantly higher specificity (97% vs. 88%, p = 0.001) and accuracy (94% vs. 86%, p = 0.018). Semiquantitative-PET parameters performed similarly, better for N (p < 0.001) than for T, slightly in favour (although not significantly) of FAPI over FDG. Conclusions: In a suspected/confirmed lung cancer surgical cohort, PET/CT performances for preoperative T&Nstaging were slightly in favour of FAPI than FDG (except for suboptimal N-sensitivity), significantly better only for N (region-based) specificity and accuracy using visual assessment. The trial’s conventional follow-up is still ongoing; future analyses are pending, including non-surgical findings and theoretical impact on patient management. Full article
(This article belongs to the Special Issue Past, Present and Future Radiotracer Techniques: Radiopharmaceuticals in Cancer Theranostics)
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15 pages, 4088 KiB  
Article
[68Ga]Ga-FAP-2286—Synthesis, Quality Control and Comparison with [18F]FDG PET/CT in a Patient with Suspected Cholangiocellular Carcinoma
by Anton Amadeus Hörmann, Gregor Schweighofer-Zwink, Gundula Rendl, Kristina Türk, Samuel Nadeje, Kristina Haas, Theresa Jung, Ursula Huber-Schönauer, Lukas Hehenwarter, Mohsen Beheshti and Christian Pirich
Pharmaceuticals 2024, 17(9), 1141; https://doi.org/10.3390/ph17091141 - 29 Aug 2024
Viewed by 1392
Abstract
[68Ga]Ga-FAP-2286 is a new peptide-based radiopharmaceutical for positron-emission tomography (PET) that targets fibroblast activation protein (FAP). This article describes in detail the automated synthesis of [68Ga]Ga-FAP-2286 using a commercially available synthesis tool that includes quality control for routine clinical [...] Read more.
[68Ga]Ga-FAP-2286 is a new peptide-based radiopharmaceutical for positron-emission tomography (PET) that targets fibroblast activation protein (FAP). This article describes in detail the automated synthesis of [68Ga]Ga-FAP-2286 using a commercially available synthesis tool that includes quality control for routine clinical applications. The synthesis was performed using a Scintomics GRP-3V module and a GMP grade 68Ge/68Ga generator. A minor alteration for transferring the eluate to the module was established, eliminating the need for new method programming. Five batches of [68Ga]Ga-FAP-2286 were tested to validate the synthesis. A stability analysis was conducted up to 3 h after production to determine the shelf-life of the finished product. The automated synthesis on the Scintomics GRP-3V synthesis module was found to be compliant with all quality control requirements. The shelf-life of the product was set to 2 h post-production based on the stability study. A patient suffering from cholangiocellular carcinoma that could not be clearly detected by conventional imaging, including a [18F]FDG-PET/CT, highlights the potential use of [68Ga]Ga-FAP-PET/CT. Full article
(This article belongs to the Special Issue Past, Present and Future Radiotracer Techniques: Radiopharmaceuticals in Cancer Theranostics)
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14 pages, 4551 KiB  
Article
Human ABC and SLC Transporters: The Culprit Responsible for Unspecific PSMA-617 Uptake?
by Harun Taş, Gábor Bakos, Ulrike Bauder-Wüst, Martin Schäfer, Yvonne Remde, Mareike Roscher and Martina Benešová-Schäfer
Pharmaceuticals 2024, 17(4), 513; https://doi.org/10.3390/ph17040513 - 16 Apr 2024
Viewed by 2217
Abstract
[177Lu]Lu-PSMA-617 has recently been successfully approved by the FDA, the MHRA, Health Canada and the EMA as Pluvicto®. However, salivary gland (SG) and kidney toxicities account for its main dose-limiting side-effects, while its corresponding uptake and retention mechanisms still [...] Read more.
[177Lu]Lu-PSMA-617 has recently been successfully approved by the FDA, the MHRA, Health Canada and the EMA as Pluvicto®. However, salivary gland (SG) and kidney toxicities account for its main dose-limiting side-effects, while its corresponding uptake and retention mechanisms still remain elusive. Recently, the presence of different ATP-binding cassette (ABC) transporters, such as human breast cancer resistance proteins (BCRP), multidrug resistance proteins (MDR1), multidrug-resistance-related proteins (MRP1, MRP4) and solute cassette (SLC) transporters, such as multidrug and toxin extrusion proteins (MATE1, MATE2-K), organic anion transporters (OAT1, OAT2v1, OAT3, OAT4) and peptide transporters (PEPT2), has been verified at different abundances in human SGs and kidneys. Therefore, our aim was to assess whether [177Lu]Lu-PSMA-617 and [225Ac]Ac-PSMA-617 are substrates of these ABC and SLC transporters. For in vitro studies, the novel isotopologue ([α,β-3H]Nal)Lu-PSMA-617 was used in cell lines or vesicles expressing the aforementioned human ABC and SLC transporters for inhibition and uptake studies, respectively. The corresponding probe substrates and reference inhibitors were used as controls. Our results indicate that [177Lu]Lu-PSMA-617 and [225Ac]Ac-PSMA-617 are neither inhibitors nor substrates of the examined transporters. Therefore, our results show that human ABC and SLC transporters play no central role in the uptake and retention of [177Lu]Lu-PSMA-617 and [225Ac]Ac-PSMA-617 in the SGs and kidneys nor in the observed toxicities. Full article
(This article belongs to the Special Issue Past, Present and Future Radiotracer Techniques: Radiopharmaceuticals in Cancer Theranostics)
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Review

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22 pages, 2130 KiB  
Review
Dual-Labeled Small Peptides in Cancer Imaging and Fluorescence-Guided Surgery: Progress and Future Perspectives
by Paul Minges, Matthias Eder and Ann-Christin Eder
Pharmaceuticals 2025, 18(2), 143; https://doi.org/10.3390/ph18020143 - 22 Jan 2025
Viewed by 617
Abstract
Dual-labeled compounds that combine radiolabeling and fluorescence labeling represent a significant advancement in precision oncology. Their clinical implementation enhances patient care and outcomes by leveraging the high sensitivity of radioimaging for tumor detection and taking advantage of fluorescence-based optical visualization for surgical guidance. [...] Read more.
Dual-labeled compounds that combine radiolabeling and fluorescence labeling represent a significant advancement in precision oncology. Their clinical implementation enhances patient care and outcomes by leveraging the high sensitivity of radioimaging for tumor detection and taking advantage of fluorescence-based optical visualization for surgical guidance. Non-invasive radioimaging facilitates immediate identification of both primary tumors and metastases, while fluorescence imaging assists in decision-making during surgery by offering a spatial distinction between malignant and non-malignant tissue. These advancements hold promise for enhancing patient outcomes and personalization of cancer treatment. The development of dual-labeled molecular probes targeting various cancer biomarkers is crucial in addressing the heterogeneity inherent in cancer pathology and recent studies had already demonstrated the impact of dual-labeled compounds in surgical decision-making (NCT03699332, NCT03407781). This review focuses on the development and application of small dual-labeled peptides in the imaging and treatment of various cancer types. It summarizes the biomarkers targeted to date, tracing their development from initial discovery to the latest advancements in peptidomimetics. Through comprehensive analysis of recent preclinical and clinical studies, the review demonstrates the potential of these dual-labeled peptides to improve tumor detection, localization, and resection. Additionally, it highlights the evolving landscape of dual-modality imaging, emphasizing its critical role in advancing personalized and effective cancer therapy. This synthesis of current research underscores the promise of dual-labeled peptides in enhancing diagnostic accuracy and therapeutic outcomes in oncology. Full article
(This article belongs to the Special Issue Past, Present and Future Radiotracer Techniques: Radiopharmaceuticals in Cancer Theranostics)
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15 pages, 2431 KiB  
Review
Non-[18F]FDG PET-Radiopharmaceuticals in Oncology
by Antonia Dimitrakopoulou-Strauss, Leyun Pan and Christos Sachpekidis
Pharmaceuticals 2024, 17(12), 1641; https://doi.org/10.3390/ph17121641 - 6 Dec 2024
Viewed by 825
Abstract
Molecular imaging is a growing field, driven by technological advances, such as the improvement of PET-CT scanners through the introduction of digital detectors and scanners with an extended field of view, resulting in much higher sensitivity and a variety of new specific radiopharmaceuticals [...] Read more.
Molecular imaging is a growing field, driven by technological advances, such as the improvement of PET-CT scanners through the introduction of digital detectors and scanners with an extended field of view, resulting in much higher sensitivity and a variety of new specific radiopharmaceuticals that allow the visualization of specific molecular pathways and even theragnostic approaches. In oncology, the development of dedicated tracers is crucial for personalized therapeutic approaches. Novel peptides allow the visualization of many different targets, such as PD-1 and PD-L1 expression, chemokine expression, HER expression, T-cell imaging, microenvironmental imaging, such as FAP imaging, and many more. In this article, we review recent advances in the development of non-[18F]FDG PET radiopharmaceuticals and their current clinical applications in oncology, as well as some future aspects. Full article
(This article belongs to the Special Issue Past, Present and Future Radiotracer Techniques: Radiopharmaceuticals in Cancer Theranostics)
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26 pages, 1339 KiB  
Review
Iodine-123 Metaiodobenzylguanidine (I-123 MIBG) in Clinical Applications: A Comprehensive Review
by Ming-Cheng Chang, Cheng-Liang Peng, Chun-Tang Chen, Ying-Hsia Shih, Jyun-Hong Chen, Yi-Jou Tai and Ying-Cheng Chiang
Pharmaceuticals 2024, 17(12), 1563; https://doi.org/10.3390/ph17121563 - 21 Nov 2024
Viewed by 1035
Abstract
Iodine-123 metaiodobenzylguanidine (I-123 MIBG) is a crucial radiopharmaceutical widely used in nuclear medicine for its diagnostic capabilities in both cardiology and oncology. This review aims to present a comprehensive evaluation of the clinical applications of I-123 MIBG, focusing on its use in diagnosing [...] Read more.
Iodine-123 metaiodobenzylguanidine (I-123 MIBG) is a crucial radiopharmaceutical widely used in nuclear medicine for its diagnostic capabilities in both cardiology and oncology. This review aims to present a comprehensive evaluation of the clinical applications of I-123 MIBG, focusing on its use in diagnosing and managing various diseases. In cardiology, I-123 MIBG has proven invaluable in assessing cardiac sympathetic innervation, particularly in patients with heart failure, where it provides prognostic information that guides treatment strategies. In oncology, I-123 MIBG is primarily utilized for imaging neuroendocrine tumors, such as neuroblastoma and pheochromocytoma, where it offers high specificity and sensitivity in the detection of adrenergic tissue. Additionally, its role in neurology, specifically in differentiating between Parkinson’s disease, dementia, and Lewy body dementia, has become increasingly significant due to its ability to identify postganglionic sympathetic dysfunction. Despite its established clinical utility, the use of I-123 MIBG is not without limitations, including variability in imaging protocols and interpretation challenges. This review will explore these issues and discuss emerging alternatives, while also highlighting areas where I-123 MIBG continues to be a gold standard. By synthesizing the current research, this article aims to provide a clear understanding of the strengths, limitations, and prospects of I-123 MIBG in clinical practice. Full article
(This article belongs to the Special Issue Past, Present and Future Radiotracer Techniques: Radiopharmaceuticals in Cancer Theranostics)
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24 pages, 10379 KiB  
Review
Theranostics Nuclear Medicine in Prostate Cancer
by Helena Lima, Marina Etchebehere, Mateos Bogoni, Caroline Torricelli, Ellen Nogueira-Lima, Victor M. Deflon, Mariana Lima and Elba Etchebehere
Pharmaceuticals 2024, 17(11), 1483; https://doi.org/10.3390/ph17111483 - 5 Nov 2024
Viewed by 1840
Abstract
Theranostic Nuclear Medicine is based on the idea of combining the same molecule (or drug) with different radioisotopes for both diagnosis and treatment, a concept that emerged in the early 1940s with the use of radioactive iodine for thyroid diseases. Theranostic Nuclear Medicine [...] Read more.
Theranostic Nuclear Medicine is based on the idea of combining the same molecule (or drug) with different radioisotopes for both diagnosis and treatment, a concept that emerged in the early 1940s with the use of radioactive iodine for thyroid diseases. Theranostic Nuclear Medicine has since expanded to diseases of higher incidence, such as prostate cancer, with several imaging methods used to assess the extent of the disease and the corresponding radiopharmaceuticals used for treatment. For example, by detecting osteoblastic metastases by bone scintigraphy, corresponding radiopharmaceuticals with therapeutic properties can be administered to eliminate or reduce pain associated with metastases and/or determine overall survival gain. The purpose of this review is to discuss the role of Theranostic Nuclear Medicine in prostate cancer, addressing the main diagnostic imaging studies with their corresponding treatments in the Theranostic model. Full article
(This article belongs to the Special Issue Past, Present and Future Radiotracer Techniques: Radiopharmaceuticals in Cancer Theranostics)
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21 pages, 841 KiB  
Review
Radiopharmaceuticals for Pancreatic Cancer: A Review of Current Approaches and Future Directions
by Sara Calistri, Giuseppe Ottaviano and Alberto Ubaldini
Pharmaceuticals 2024, 17(10), 1314; https://doi.org/10.3390/ph17101314 - 1 Oct 2024
Viewed by 2338
Abstract
The poor prognosis of pancreatic cancer requires novel treatment options. This review examines the evolution of radiopharmaceuticals in the treatment of pancreatic cancer. Established strategies such as peptide receptor radionuclide therapy (PRRT) offer targeted and effective treatment, compared to conventional treatments. However, there [...] Read more.
The poor prognosis of pancreatic cancer requires novel treatment options. This review examines the evolution of radiopharmaceuticals in the treatment of pancreatic cancer. Established strategies such as peptide receptor radionuclide therapy (PRRT) offer targeted and effective treatment, compared to conventional treatments. However, there are currently no radiopharmaceuticals approved for the treatment of pancreatic cancer in Europe, which requires further research and novel approaches. New radiopharmaceuticals including radiolabeled antibodies, peptides, and nanotechnological approaches are promising in addressing the challenges of pancreatic cancer therapy. These new agents may offer more specific targeting and potentially improve efficacy compared to traditional therapies. Further research is needed to optimize efficacy, address limitations, and explore the overall potential of these new strategies in the treatment of this aggressive and harmful pathology. Full article
(This article belongs to the Special Issue Past, Present and Future Radiotracer Techniques: Radiopharmaceuticals in Cancer Theranostics)
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