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NCT Number: NCT04104529

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

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

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Key information

About this study

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 emitters less (Iodine-131, Lutecium-177), alpha (Radium-223) or Auger (Indium-111). They will target tumor cells either by natural tropism (iodine for thyroid cancer, for example) or by coupling them to a vector (antibody, peptide ...).

Patients with thyroid cancer, prostate cancer or neuroendocrine tumors 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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

Treatment and study plan

Biological collection

Other

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

tumor collection

Other

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

Primary outcomes

  1. Proportion of patients who gave their consent to participate in the study

    Time frame: Until the study completion: 5 years

    The proportion of patients who consent to participate in the study among the screened patients

Study contacts

Contact information is provided by the study sponsor or research team.

Aurore MOUSSION

CONTACT

[email protected]

0467613102 ext. +33

Sponsors and collaborators

Lead sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Other

Registry information

Official study title

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

Acronym: BCB RIV

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Sep 26, 2019
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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