Pharmaceutical Management in Targeted Radioligand Therapy

Recruiting now

Conditions studied: Cancer, Thyroid Cancer, Metastatic Prostate Cancer, Neuroendocrine Tumor Carcinoid

In brief

Targeted Radionuclide Therapy (TRT) is a treatment modality used in nuclear medicine to target cancer cells while preserving surrounding healthy tissues. This approach is based on the use of radiopharmaceuticals (RPs)-compounds that combine a radioactive isotope with a molecule designed to selectively bind to cancer cells. TRT has historical roots, dating back to the 1950s with the introduction of radioactive iodine-131. It has long been used for the treatment of thyroid cancers, which require hospitalization for 3 to 5 days in a dedicated, isolated, and radioprotected environment. In recent years, TRT has undergone significant development with the emergence of new isotopes coupled with innovative molecules targeting a wider range of cancers. Lutathera (\[177Lu\]Lu-DOTATATE) and Pluvicto (\[177Lu\]Lu-PSMA-617), available since 2021, have revolutionized the management of patients with neuroendocrine tumors and metastatic prostate cancer, respectively. Numerous clinical trials are currently underway or planned, further expanding the field. These cutting-edge treatments are administered intravenously-mostly on an outpatient basis-within nuclear medicine departments under strict radioprotection protocols. More recently, several healthcare institutions in France have introduced systematic clinical pharmacy activities for all patients treated with TRT, allowing for pharmaceutical validation of patient care. These activities may include: A medication reconciliation (MR): a comprehensive list of all current and planned medications, gathered from at least three sources (e.g., prescriptions, general practitioner, medical records, and a pharmacist-led interview to gather additional details); A basic prescription review without medication history collection; Medication reconciliation at hospital admission or discharge. These activities, carried out by the radiopharmacist, aim to lead to a pharmaceutical intervention (PI)-a proposal to modify a medical prescription in response to a detected medication-related issue. This project aims to evaluate the impact of radiopharmacy activities, particularly medication reconciliation and pharmacist-patient interviews, in securing the care pathway for patients undergoing TRT. A key component of this work is the creation of a national collaborative database, in partnership with the French Society of Radiopharmacy (SOFRA). This database will also document the range of clinical radiopharmacy activities implemented across different institutions, their feasibility, the pharmaceutical interventions made, and their contributions to patient monitoring and safety.

Key facts

Study ID

NCT07389512

Run by

Hospices Civils de Lyon

People needed

600

Starts

2026-01-09

Expected to finish

2029-09-30

Last updated by the study team

2026-02-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All adult patients treated in nuclear medicine with pharmaceutical validation for a first Targeted Radionuclide Therapy (TRT) will be included in the database.
• All patients for whom a pharmaceutical intervention (PI) has been made, whether for a first or subsequent TRT.

You may not qualify if…

• Minor patient
• Patient without a pharmaceutical intervention for a treatment other than the first TRT course

Where it is running

• Hospices Civils de Lyon — Bron, France (enrolling)
• CGFL Dijon — Dijon, France
• Centre Hospitalier Universitaire de Lille — Lille, France

Full record on ClinicalTrials.gov

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