Gustave Roussy Authorised to Conduct Phase I Clinical Trials in Nuclear Medicine

In 2024, the Nuclear Safety and Radiation Protection Authority (ASNR) and the Regional Health Agency (ARS) Île-de-France authorised Gustave Roussy to conduct Phase I trials in nuclear medicine, the first stage in the clinical validation process of a new treatment. The Institute can now evaluate innovative radioligands administered for the first time or at an early stage in humans. Previously, the Nuclear Medicine Division at Gustave Roussy, part of the Medical Imaging Department, was authorised to treat patients with these drugs once they were commercially available or in Phase II-III development.

Radionuclide therapy (RNT) is a nuclear medicine treatment modality currently undergoing numerous innovations. It involves administering a radioactive drug (radiopharmaceutical) specifically designed to target tumour cells, thereby destroying them while preserving healthy tissue.

Several innovative radiopharmaceuticals are under development. Gustave Roussy is now authorised to conduct Phase I trials in nuclear medicine to assess these new treatments in humans for the first time or at an early stage. The Institute also aims to contribute to developing innovative multimodal therapeutic strategies.

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First Patient Treated

In January 2025, the nuclear medicine division at Gustave Roussy, in collaboration with the Department of Therapeutic Innovation and Early Trials (DITEP), treated its first patient in a Phase I nuclear medicine clinical trial. The patient, diagnosed with metastatic breast cancer, received [177Lu]Lu-NeoB, a radiopharmaceutical targeting the bombesin receptor, which is frequently overexpressed in certain cancers, including breast cancer.

This first administration marks the official launch of Phase I clinical trials in this field, an area that remains underdeveloped in France and Europe due to significant organisational and regulatory constraints.

"Obtaining ASNR authorisation in 2024 was made possible thanks to the infrastructure and expertise developed at Gustave Roussy. We had to demonstrate our ability to ensure a safe pathway for both patients and healthcare professionals, to maintain laboratories capable of handling radioligands, and to conduct precise dosimetry analyses for each administration. The team successfully met these challenges by establishing the entire framework necessary to carry out these studies," said Dr Désirée Deandreis, Head of the Nuclear Medicine Division at Gustave Roussy.

Commitment to Innovation

In the coming months and years, Gustave Roussy plans to expand its trials and broaden radiopharmaceutical indications to other tumour types, including digestive, pancreatic, lung, and brain cancers. The long-term goal is to further enhance the Institute’s capacity to conduct these studies by equipping its radiopharmacy for the in-house production of innovative radiopharmaceuticals.

Through this ambitious programme, Gustave Roussy reaffirms its commitment to innovation and clinical research, striving to provide patients with increasingly targeted and effective treatments.