Clinical Trials in Molecular Radiotherapy: An Overview of the Landscape

Area of Science:

• Oncology
• Radiochemistry
• Clinical Trials

Background:

• Molecular radiotherapy (MRT) is an emerging cancer treatment modality.
• It complements non-radioactive drugs (NRDs) and external beam radiotherapy (EBRT).
• Understanding the evolution of MRT clinical trials is crucial for assessing its impact.

Purpose of the Study:

• To analyze the trends and evolution of molecular radiotherapy (MRT) clinical trials.
• To compare the growth of MRT trials with other cancer treatment modalities like NRDs and EBRT.
• To identify changes in trial indications and radionuclide usage in MRT.

Main Methods:

• A Python-based tool was developed to analyze clinical trial data.
• Data was sourced from the ClinicalTrials.gov database for the period 2000-2024.
• Trends in trial registration, phase, indications, and radionuclide types were examined.

Main Results:

• MRT clinical trials increased 15-fold from 6 in 2000 to 89 in 2024.
• The ratio of MRT to EBRT trials remained stable at approximately 1:5.
• MRT trial frequency relative to NRD trials doubled, with a higher proportion of early-phase trials.

Conclusions:

• Molecular radiotherapy (MRT) is experiencing significant growth in clinical trial activity.
• Trial registrations have increased across most cancer types, notably prostate, neuroendocrine, and liver cancers.
• Beta-minus emitting radionuclides dominate current MRT trials, with a growing diversity of agents and applications.