CancerPharmTRTNCT07389512
Pharmaceutical Management in Targeted Radioligand Therapy
An observational study of Cancer and Thyroid Cancer, run by Hospices Civils de Lyon at 3 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Thyroid Cancer, Metastatic Prostate Cancer
- How many people
- 600 participants
- Where
- 3 sitesFrance
- Study dates
- 9 Jan 2026to 30 Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patient managed in nuclear medicine for Targeted Radionuclide Therapy (TRT) and for whom pharmaceutical validation was performed by a radiopharmacist.
Who may be able to join
- 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.
Who cannot join
- Minor patient
- Patient without a pharmaceutical intervention for a treatment other than the first TRT course
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
Hospices Civils de Lyon
Bron, 69677
- Not yet recruiting
CGFL Dijon
Dijon, 21000
Matthieu GALLET, PharmD, +33 (0)3.80.73.77.76 ext. +33, mgallet@cgfl.fr
- Not yet recruiting
Centre Hospitalier Universitaire de Lille
Lille
Berengere Marchand, MD, +33 (0)3.20.44.64.19, berengere.marchand@chu-lille.fr
About this study
Official title: Development and Evaluation of Clinical Radiopharmacy in the Pharmaceutical Management of Patients Treated With Targeted Radionuclide Therapy (TRT) Within Nuclear Medicine Departments
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.
Read more
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.
- Keywords
- Clinical radiopharmacy, Pharmaceutical consultation, Targeted Radionuclide Therapy
- Medical subject headings
- Neoplasms, Thyroid Neoplasms, Prostatic Neoplasms, Carcinoid Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| TRT Cohort | Cohorte of patients treated with Targeted Radionuclide Therapy for thyroid cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Comparison of patient care pathway safety, as measured by the rate of pharmaceutical interventions (i.e., standardized prescription modification proposals made by the radiopharmacist), in patients receiving their first Targeted Radiotherapy (TRT), following pharmaceutical validation including a medication reconciliation, versus validation based solely on the patient's medical and laboratory data.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start9 Jan 2026
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07389512
- Sponsor's protocol ID
- 69HCL25_0917
- Other IDs
- 25-5201
- Acronym
- PharmTRT
- Status last verified
- Jan 2026
- First submitted
- 29 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of Clinical Radiopharmacy in the Pharmaceutical Management of Patients Treated With Targeted Radionuclide Therapy (TRT) Within Nuclear Medicine Departments
- ClinicalTrials.gov ID
- NCT07389512
- Acronym / sponsor ID
- PharmTRT / 69HCL25_0917
- Keywords
- Clinical radiopharmacy, Pharmaceutical consultation, Targeted Radionuclide Therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 9 Jan 2026 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TRT Cohort | – | –Cohorte of patients treated with Targeted Radionuclide Therapy for thyroid cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient managed in nuclear medicine for Targeted Radionuclide Therapy (TRT) and for whom pharmaceutical validation was performed by a radiopharmacist.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Minor patient
- Patient without a pharmaceutical intervention for a treatment other than the first TRT course
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Comparison of patient care pathway safety, as measured by the rate of pharmaceutical interventions (i.e., standardized prescription modification proposals made by the radiopharmacist), in patients receiving their first Targeted Radiotherapy (TRT), following pharmaceutical validation including a medication reconciliation, versus validation based solely on the patient's medical and laboratory data.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Thyroid Cancer, run by Hospices Civils de Lyon at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah CHAIB, PharmD (+ 33 (0)4 27 85 54 14, Sarah.chaib@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.