Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT04290663
PHASE3

Systematic Radioiodine Administration Versus Decision of Radioiodine Treatment Guided by a Post-operative Work-up

Sponsor: Centre Francois Baclesse

View on ClinicalTrials.gov

Summary

This trial is comparing two strategies in intermediate-risk differentiated thyroid cancer patients: Systematic radioiodine administration versus decision of radioiodine treatment guided by a post-operative work-up based on serum Tg values and diagnostic RAI scintigraphy

Official title: Multicentric Phase III Trial Comparing Two Strategies in Intermediate-risk Differentiated Thyroid Cancer Patients: Systematic Radioiodine Administration Versus Decision of Radioiodine Treatment Guided by a Post-operative Work-up Based on Serum Tg Values and Diagnostic RAI Scintigraphy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

476

Start Date

2020-03-02

Completion Date

2033-02

Last Updated

2025-10-14

Healthy Volunteers

No

Interventions

DRUG

Systematic RAI-treatment

Administration of 3.7 GBq (100 mCi) or 1,1 GBq (30 mCi) of I131 at the choice of the investigator after rhTSH-stimulation

OTHER

Decision of RAI-treatment guided by a post-operative assessment

The decision-making for the administration of an adapted RAI-treatment will be taken according to the following criteria: * No RAI treatment if Tg/LT4 ≤1 ng/mL and rhTSH-sTg ≤10 ng/mL and normal diagnostic RAI-scintigraphy * 1.1 GBq after rhTSH if Tg/LT4\>1 ng/mL or rhTSH-sTg\>10 ng/mL and normal diagnostic RAI-scintigraphy. * 3.7 GBq after rhTSH if metastatic lymph-node(s) detected on diagnostic RAI-scintigraphy without distant metastasis * 3.7 GBq after hormone withdrawal if distant metastasis detected on diagnostic RAI-scintigraphy or on the hybrid CT scan of the SPECT-CT acquisition

Locations (29)

CHU Pointe à pitre

Pointe à Pitre, Guadeloupe, France

Chu Angers

Angers, France

Institu de Cancérologie de l'Ouest - Site Angers

Angers, France

Bergonié

Bordeaux, France

Hôpital saint-André

Bordeaux, France

Chu Brest

Brest, France

Centre Francois Baclesse

Caen, France

Centre Hospitalier Métropôle Savoie

Chambéry, France

Centre Jean Perrin

Clermont-Ferrand, France

Centre Georges-François Leclerc

Dijon, France

Chu Martinique

Fort de France, France

Chu Grenoble

Grenoble, France

Chru Lille

Lille, France

Centre Léon Bérard

Lyon, France

Hospices Civils de Lyon

Lyon, France

CHU Timone

Marseille, France

Chu Nancy

Nancy, France

Chu Nantes

Nantes, France

Centre Antoine Lacassagne -

Nice, France

Chu Nimes

Nîmes, France

AP-HP Pitié Salpétrière

Paris, France

Centre Jean Godinot

Reims, France

Centre Henri Becquerel

Rouen, France

Institut CURIE, site Réné Huguenin

Saint-Cloud, France

Institu de Cancérologie de l'Ouest - Site St Herblain

Saint-Herblain, France

Centre Paul Strauss

Strasbourg, France

CHU TOULOUSE, Hôpital Larrey

Toulouse, France

IUCT Oncopole

Toulouse, France

Institut Gustave Roussy

Villejuif, France