Pharmaceutical Management in Targeted Radioligand Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cancer, Thyroid Cancer, Metastatic Prostate Cancer, Neuroendocrine Tumor Carcinoid. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Development and Evaluation of Clinical Radiopharmacy in the Pharmaceutical Management of Patients Treated With Targeted Radionuclide Therapy (TRT) Within Nuclear Medicine Departments
Overview
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.
Primary outcome measures
- To evaluate the contribution of conducting a medication reconciliation to improve the safety of the care pathway for patients receiving their first Targeted Radiotherapy (initial course), compared to care without medication reconciliation [Time frame: The pharmaceutical intervention will be measured at the time of interview with the patient in the group medication reconciliation AND before RIV treatment or treatment pharmaceutic order in the group solely on the patient's medical and laboratory data]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Minor patient
- Patient without a pharmaceutical intervention for a treatment other than the first TRT course
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 3 centers
- Hospices Civils de Lyon — Bron
- CGFL Dijon — Dijon
- Centre Hospitalier Universitaire de Lille — Lille
Identifiers
NCT: NCT07389512 · 69HCL25_0917 · 25-5201