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Clinico-biological Database in Patients Treated With Metabolic Radiotherapy in the Nuclear Medicine Department

Establishment of a Clinico-biological Database in Patients Treated With Metabolic Radiotherapy in the Nuclear Medicine Department

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04104529
Acronym
BCB RIV
Enrollment
350
Registered
2019-09-26
Start date
2019-10-28
Completion date
2029-10-01
Last updated
2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Meningioma, Neuroendocrine Tumors, Prostate Cancer, SSTR Positive Tumors, Thyroid Cancer

Keywords

thyroid cancer, prostate cancer, neuroendocrine tumors, nuclear medecine, SSTR positive tumors, meningiomas

Brief summary

Development of a clinico-biological database allowing the provision of clinical data and corresponding biological materials to the medical and scientific community.

Detailed description

Targeted radionuclide therapy (TRT) aims at delivering ionizing radiation specifically to tumors for therapeutic purposes. Different types of radionuclides can be used to deliver the radiation: beta minus emitters less (ie Iodine-131, Lutecium-177), alpha (Actinium-225, Radium-223) or Auger (Indium-111). They will target tumor cells either by natural tropism (iodine for thyroid cancer, for example) or by coupling to a specific vector (antibody, peptides or small molecules) recognizing particular tumor targets, such as somatostatin receptors in neuroendocrine tumors and certain meningiomas (177Lu-DOTATATE, Lutathera®) or prostate specific membrane antigen (PSMA) in metastatic prostate cancers (177Lu-PSMA-617, Pluvicto®). Patients with thyroid cancer, prostate cancer, neuroendocrine tumors or SSTR positive tumours (like meningiomas) who should benefit form TRT may be included in this project. The clinical-biological database will help better understanding of the radiobiological mechanisms of action of ionizing radiations on both normal tissues and tumor cells and the psycho-oncological mechanisms involved in patients treated with TRT (only for ICM's patients). The collected data will help treatment optimization. To meet these demands, the research must then integrate databases creation open to researchers and the ongoing evaluation of the impact of projects on the health of cancer patients. Integrated research associated with quality biological research is the guarantee of medical progress. The multidisciplinary structure around collections of biological resources will enable the various actors to harmonize not only the collection but also the sharing of their data with a view to making them available for medico-scientific projects at a regional and national dimension. The Clinical Biological Database (BCB) should be used to identify and characterize new molecular markers for better diagnosis and / or treatment. It should also permit to optimize the collection of all this information, their integration and their transversal exploitation by different research disciplines (epidemiological, fundamental, translational, clinical). An ancillary study "IMMUNORIV" is associated to BCB RIV : The specific research aim is, first, to determine whether immune cell (lymphocytes and macrophages) scoring and characterization in metastatic thyroid cancer and NET samples at diagnosis predict the response to TRT. Second, a high-throughput approach will be used to determine i) the immune cell profile in blood samples from patients with NET, before and after TRT initiation, and ii) its possible correlation with the response to TRT. Third, using imaging techniques the possible correlation will be evaluated between tumor uptake/absorbed dose and response to TRT. By monitoring the immune response during TRT, the IMMUNORIV project will allow to identify immune response-related biomarkers that may be modulated to improve TRT effect.

Interventions

OTHERBiological collection

The biological collection will also include samples of blood samples collected before and during treatment.

Tumor collection (diagnosis) will be done for thyroid cancer and neuroencrine

Sponsors

Institut du Cancer de Montpellier - Val d'Aurelle
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age ≥ at 18 years old, * Patient treated in the Nuclear Medicine Department for the treatment by metabolic radiotherapy, * Patient treated as part of his treatment for: * thyroid cancer, * a neuroendocrine tumor or any SSTR positive tumours (like meningiomas) receiving PRRT * prostate cancer. * Patient having accepted the complementary blood sample, * Patient having given his informed, written and express consent.

Exclusion criteria

* Patient not affiliated to a social security scheme, * Subject under tutelage, curatorship or safeguard of justice, * Patient in an emergency situation * Patient whose regular monitoring is a priori impossible for psychological, family, social or geographical reasons, * Pregnant and / or breastfeeding woman

Design outcomes

Primary

MeasureTime frameDescription
Proportion of patients who gave their consent to participate in the studyUntil the study completion: 5 yearsThe proportion of patients who consent to participate in the study among the screened patients

Countries

France

Contacts

CONTACTAurore MOUSSION
DRCI-icm105@icm.unicancer.fr0467613102
STUDY_CHAIREmmanuel DESHAYES, MD

Institut régional du Cancer Montpellier

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 16, 2026