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RecruitingNCT04104529BCB RIVUpdated Sep 15, 2026

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

An interventional study of Biological collection and tumor collection in Thyroid Cancer, Prostate Cancer and Neuroendocrine Tumors, sponsored by Institut du Cancer de Montpellier - Val d'Aurelle. Recruiting at 4 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.

Sponsored by Institut du Cancer de Montpellier - Val d'Aurelle · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Oct 2019; still recruiting 7 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
350
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

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

Keywords

  • thyroid cancer
  • prostate cancer
  • neuroendocrine tumors
  • nuclear medecine
  • SSTR positive tumors
  • meningiomas
03

In context

Thyroid Neoplasms

785 studies on the registry are indexed under Thyroid Neoplasms; 204 are open to participants now.

This study's planned enrollment of 350 is above the median of 53 across 520 interventional studies indexed under Thyroid Neoplasms.

Browse Thyroid Neoplasms studies →

Lead sponsor

Institut du Cancer de Montpellier - Val d'Aurelle is the lead sponsor of 142 studies on the registry; 47 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
350 participants (estimated)

Study arms

  • Experimental
    Biological collection

    Biological collection For all the patients include in the study : samples of blood samples collected before and during treatment. In parallel to this biological collection, standardized clinical data will be entered into a database Ancillary study : For metastatic thyroïd cancer and neuroendocrine tumor : anapath blocks of the initial diagnosis will be archived and dosimetric data will be collected for the cycle 1 For neuroendocrine tumor : blood sample additionnal will be realized at the cycle 1 (pre and post treatment)

    Other: Biological collection · Other: tumor collection

Interventions

  • OtherBiological collection

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

  • Othertumor collection

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

06

What researchers measure

Primary outcomes

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

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

    Time frame: Until the study completion: 5 years

07

Study locations

3 of 4 sites recruiting
08

References and documents

Publications

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  • Kumar C, Shetake N, Desai S, Kumar A, Samuel G, Pandey BN. Relevance of radiobiological concepts in radionuclide therapy of cancer. Int J Radiat Biol. 2016;92(4):173-86. doi: 10.3109/09553002.2016.1144944. Epub 2016 Feb 26. PubMed 26917443 ↗
  • Gudkov SV, Shilyagina NY, Vodeneev VA, Zvyagin AV. Targeted Radionuclide Therapy of Human Tumors. Int J Mol Sci. 2015 Dec 28;17(1):33. doi: 10.3390/ijms17010033. PubMed 26729091 ↗
  • Schlumberger M, Catargi B, Borget I, Deandreis D, Zerdoud S, Bridji B, Bardet S, Leenhardt L, Bastie D, Schvartz C, Vera P, Morel O, Benisvy D, Bournaud C, Bonichon F, Dejax C, Toubert ME, Leboulleux S, Ricard M, Benhamou E; Tumeurs de la Thyroide Refractaires Network for the Essai Stimulation Ablation Equivalence Trial. Strategies of radioiodine ablation in patients with low-risk thyroid cancer. N Engl J Med. 2012 May 3;366(18):1663-73. doi: 10.1056/NEJMoa1108586. PubMed 22551127 ↗
  • Dizdarevic S, Tulchinsky M, McCready VR, Mihailovic J, Vinjamuri S, Buscombe JR, Lee ST, Frangos S, Sathekge M, Siraj Q, Choudhury P, Bom H, Franceschi M, Ugrinska A, Paez D, Hussain R, Mailman J, Luster M, Virgolini I; WARMTH Thyroid Group. The World Association of Radiopharmaceutical and Molecular Therapy position statement on the initial radioiodine therapy for differentiated thyroid carcinoma. World J Nucl Med. 2019 Apr-Jun;18(2):123-126. doi: 10.4103/wjnm.WJNM_117_18. No abstract available. PubMed 31040741 ↗
  • Strosberg J, El-Haddad G, Wolin E, Hendifar A, Yao J, Chasen B, Mittra E, Kunz PL, Kulke MH, Jacene H, Bushnell D, O'Dorisio TM, Baum RP, Kulkarni HR, Caplin M, Lebtahi R, Hobday T, Delpassand E, Van Cutsem E, Benson A, Srirajaskanthan R, Pavel M, Mora J, Berlin J, Grande E, Reed N, Seregni E, Oberg K, Lopera Sierra M, Santoro P, Thevenet T, Erion JL, Ruszniewski P, Kwekkeboom D, Krenning E; NETTER-1 Trial Investigators. Phase 3 Trial of 177Lu-Dotatate for Midgut Neuroendocrine Tumors. N Engl J Med. 2017 Jan 12;376(2):125-135. doi: 10.1056/NEJMoa1607427. PubMed 28076709 ↗
  • Strosberg JR, Halfdanarson TR, Bellizzi AM, Chan JA, Dillon JS, Heaney AP, Kunz PL, O'Dorisio TM, Salem R, Segelov E, Howe JR, Pommier RF, Brendtro K, Bashir MA, Singh S, Soulen MC, Tang L, Zacks JS, Yao JC, Bergsland EK. The North American Neuroendocrine Tumor Society Consensus Guidelines for Surveillance and Medical Management of Midgut Neuroendocrine Tumors. Pancreas. 2017 Jul;46(6):707-714. doi: 10.1097/MPA.0000000000000850. PubMed 28609356 ↗
  • Parker C, Nilsson S, Heinrich D, Helle SI, O'Sullivan JM, Fossa SD, Chodacki A, Wiechno P, Logue J, Seke M, Widmark A, Johannessen DC, Hoskin P, Bottomley D, James ND, Solberg A, Syndikus I, Kliment J, Wedel S, Boehmer S, Dall'Oglio M, Franzen L, Coleman R, Vogelzang NJ, O'Bryan-Tear CG, Staudacher K, Garcia-Vargas J, Shan M, Bruland OS, Sartor O; ALSYMPCA Investigators. Alpha emitter radium-223 and survival in metastatic prostate cancer. N Engl J Med. 2013 Jul 18;369(3):213-23. doi: 10.1056/NEJMoa1213755. PubMed 23863050 ↗
  • Domenech A, Notta P, Benitez A, Ramal D, Rodriguez-Bel L, Massuet C, Martin-Comin J. [Evaluation of the anxiety state in patients receiving radioiodine treatment or who undergo a sentinel lymph node examination in the Nuclear Medicine Department]. Rev Esp Med Nucl. 2010 Mar-Apr;29(2):63-72. doi: 10.1016/j.remn.2009.12.009. Epub 2010 Feb 18. Spanish. PubMed 20167394 ↗
  • Mitchell AJ, Chan M, Bhatti H, Halton M, Grassi L, Johansen C, Meader N. Prevalence of depression, anxiety, and adjustment disorder in oncological, haematological, and palliative-care settings: a meta-analysis of 94 interview-based studies. Lancet Oncol. 2011 Feb;12(2):160-74. doi: 10.1016/S1470-2045(11)70002-X. Epub 2011 Jan 19. PubMed 21251875 ↗
  • Arrieta O, Angulo LP, Nunez-Valencia C, Dorantes-Gallareta Y, Macedo EO, Martinez-Lopez D, Alvarado S, Corona-Cruz JF, Onate-Ocana LF. Association of depression and anxiety on quality of life, treatment adherence, and prognosis in patients with advanced non-small cell lung cancer. Ann Surg Oncol. 2013 Jun;20(6):1941-8. doi: 10.1245/s10434-012-2793-5. Epub 2012 Dec 22. PubMed 23263699 ↗
  • Barbus E, Pestean C, Larg MI, Gabora K, Bonci EA, Badulescu C, Piciu A. Psychological impact of 131I radioprotection measures on thyroid cancer patients. Clujul Med. 2018 Oct;91(4):441-447. doi: 10.15386/cjmed-1042. Epub 2018 Oct 30. PubMed 30564021 ↗
  • De Vincentis G, Frantellizzi V, Follacchio GA, Farcomeni A, Pani A, Samaritani R, Schinzari G, Santini D, Cortesi E. No evidence of association between psychological distress and pain relief in patients with bone metastases from castration-resistant prostate cancer treated with 223Radium. Eur J Cancer Care (Engl). 2019 Sep;28(5):e13112. doi: 10.1111/ecc.13112. Epub 2019 May 31. PubMed 31148330 ↗
  • Strosberg J, Wolin E, Chasen B, Kulke M, Bushnell D, Caplin M, Baum RP, Kunz P, Hobday T, Hendifar A, Oberg K, Sierra ML, Thevenet T, Margalet I, Ruszniewski P, Krenning E; NETTER-1 Study Group. Health-Related Quality of Life in Patients With Progressive Midgut Neuroendocrine Tumors Treated With 177Lu-Dotatate in the Phase III NETTER-1 Trial. J Clin Oncol. 2018 Sep 1;36(25):2578-2584. doi: 10.1200/JCO.2018.78.5865. Epub 2018 Jun 7. PubMed 29878866 ↗
  • Prieto JM, Blanch J, Atala J, Carreras E, Rovira M, Cirera E, Gasto C. Psychiatric morbidity and impact on hospital length of stay among hematologic cancer patients receiving stem-cell transplantation. J Clin Oncol. 2002 Apr 1;20(7):1907-17. doi: 10.1200/JCO.2002.07.101. PubMed 11919251 ↗
  • Kim Y, Spillers RL. Quality of life of family caregivers at 2 years after a relative's cancer diagnosis. Psychooncology. 2010 Apr;19(4):431-40. doi: 10.1002/pon.1576. PubMed 19399773 ↗
  • Lloyd-Williams M, Dennis M, Taylor F. A prospective study to determine the association between physical symptoms and depression in patients with advanced cancer. Palliat Med. 2004 Sep;18(6):558-63. doi: 10.1191/0269216304pm923oa. PubMed 15453627 ↗
  • Satin JR, Linden W, Phillips MJ. Depression as a predictor of disease progression and mortality in cancer patients: a meta-analysis. Cancer. 2009 Nov 15;115(22):5349-61. doi: 10.1002/cncr.24561. PubMed 19753617 ↗
  • Pinquart M, Duberstein PR. Depression and cancer mortality: a meta-analysis. Psychol Med. 2010 Nov;40(11):1797-810. doi: 10.1017/S0033291709992285. Epub 2010 Jan 20. PubMed 20085667 ↗
  • Schouten B, Avau B, Bekkering GTE, Vankrunkelsven P, Mebis J, Hellings J, Van Hecke A. Systematic screening and assessment of psychosocial well-being and care needs of people with cancer. Cochrane Database Syst Rev. 2019 Mar 26;3(3):CD012387. doi: 10.1002/14651858.CD012387.pub2. PubMed 30909317 ↗
  • Pirl WF, Fann JR, Greer JA, Braun I, Deshields T, Fulcher C, Harvey E, Holland J, Kennedy V, Lazenby M, Wagner L, Underhill M, Walker DK, Zabora J, Zebrack B, Bardwell WA. Recommendations for the implementation of distress screening programs in cancer centers: report from the American Psychosocial Oncology Society (APOS), Association of Oncology Social Work (AOSW), and Oncology Nursing Society (ONS) joint task force. Cancer. 2014 Oct 1;120(19):2946-54. doi: 10.1002/cncr.28750. Epub 2014 May 2. PubMed 24798107 ↗
  • Wu HX, Zhong H, Xu YD, Xu CP, Zhang Y, Zhang W. Psychological and behavioral intervention improves the quality of life and mental health of patients suffering from differentiated thyroid cancer treated with postoperative radioactive iodine-131. Neuropsychiatr Dis Treat. 2016 May 2;12:1055-60. doi: 10.2147/NDT.S105460. eCollection 2016. PubMed 27194911 ↗
  • Dolbeault S, Bredart A, Mignot V, Hardy P, Gauvain-Piquard A, Mandereau L, Asselain B, Medioni J. Screening for psychological distress in two French cancer centers: feasibility and performance of the adapted distress thermometer. Palliat Support Care. 2008 Jun;6(2):107-17. doi: 10.1017/S1478951508000187. PubMed 18501045 ↗
  • Shou J, Zhang Z, Lai Y, Chen Z, Huang J. Worse outcome in breast cancer with higher tumor-infiltrating FOXP3+ Tregs : a systematic review and meta-analysis. BMC Cancer. 2016 Aug 26;16(1):687. doi: 10.1186/s12885-016-2732-0. PubMed 27566250 ↗
  • Constanzo J, Parach A, David T, Karam J, Bruchertseifer F, Morgenstern A, Jarlier M, Bardies M, Deshayes E, Gudin-de-Vallerin A, Boissiere-Michot F, Lopez-Crapez E, Pouget JP. MHC-I-Driven Antitumor Immunity Counterbalances Low Absorbed Doses of Radiopharmaceutical Therapy. J Nucl Med. 2025 May 1;66(5):785-792. doi: 10.2967/jnumed.124.268857. PubMed 40015918 ↗
  • Sartor O, de Bono J, Chi KN, Fizazi K, Herrmann K, Rahbar K, Tagawa ST, Nordquist LT, Vaishampayan N, El-Haddad G, Park CH, Beer TM, Armour A, Perez-Contreras WJ, DeSilvio M, Kpamegan E, Gericke G, Messmann RA, Morris MJ, Krause BJ; VISION Investigators. Lutetium-177-PSMA-617 for Metastatic Castration-Resistant Prostate Cancer. N Engl J Med. 2021 Sep 16;385(12):1091-1103. doi: 10.1056/NEJMoa2107322. Epub 2021 Jun 23. PubMed 34161051 ↗
  • Hartrampf PE, Hanscheid H, Kertels O, Schirbel A, Kreissl MC, Flentje M, Sweeney RA, Buck AK, Polat B, Lapa C. Long-term results of multimodal peptide receptor radionuclide therapy and fractionated external beam radiotherapy for treatment of advanced symptomatic meningioma. Clin Transl Radiat Oncol. 2020 Mar 5;22:29-32. doi: 10.1016/j.ctro.2020.03.002. eCollection 2020 May. PubMed 32195377 ↗
  • Frances SM, Murray L, Nicklin E, Velikova G, Boele F. Long-term health-related quality of life in meningioma survivors: A mixed-methods systematic review. Neurooncol Adv. 2024 Jan 19;6(1):vdae007. doi: 10.1093/noajnl/vdae007. eCollection 2024 Jan-Dec. PubMed 38375359 ↗
  • Fizazi K, Morris MJ, Shore ND, Chi KN, Crosby M, de Bono JS, Herrmann K, Roubaud G, Nagarajah J, Fleming M, Lewis B, Nordquist L, Carnahan N, Ghebremariam S, Hertelendi M, Castellano D, Sartor O. Health-related quality of life, pain, and symptomatic skeletal events with [177Lu]Lu-PSMA-617 in patients with progressive metastatic castration-resistant prostate cancer (PSMAfore): an open-label, randomised, phase 3 trial. Lancet Oncol. 2025 Jul;26(7):948-959. doi: 10.1016/S1470-2045(25)00189-5. Epub 2025 May 26. PubMed 40441170 ↗

Individual participant data

Plan to share: Yes — All data will be available after publication of the results in peer-reviewed revues, and in national and international meetings. It includes all de-identified participants' data, the study protocol, the statistical analysis plan and the clinical study report. The corresponding author will provide data and datasets generated and/or analyzed during the study upon reasonable request.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

Time frame: Access to study data upon written detailed request sent to ICM, from 6 months until 5 years after publication of summary data.

Access criteria: The data shared will be limit to that required for independent mandated verification of the published results, the applicant will need authorization from ICM for personal access, and data will only be transferred after signing of a data access agreement.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04104529
Responsible party
Sponsor
First posted
Sep 26, 2019
Start date
Oct 28, 2019
Primary completion
Oct 2029 (estimated)
Completion
Oct 2029 (estimated)
Last update
Sep 15, 2026

Study contacts

Aurore MOUSSION
Contact
DRCI-icm105@icm.unicancer.fr
0467613102 ext. +33
Emmanuel DESHAYES, MD
study chair · Institut régional du Cancer Montpellier

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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