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Prospective Study Evaluating the Medullary Thyroid Cancer Management's Care Using PET F-DOPA

Prospective Study Evaluating the Medullary Thyroid Cancer Management's Care Using PET F-DOPA in Patients With a High Level of Postoperative Residual Thyrocalcitonin (CMTpostopFDOPA)

Type d'étude Promoteur Etat actuel de l'étude

Interventionnelle (essai clinique)

Institut Claudius Regaud - Toulouse En cours de recrutement

 

Prospective Study Evaluating the Medullary Thyroid Cancer Management's Care Using PET F-DOPA in Patients With a High Level of Postoperative Residual Thyrocalcitonin (CMTpostopFDOPA)

Code de l’étude

NCT02856347

Promoteur

Toulouse, Institut Claudius Regaud

Tumeur éligible

MedullaryThyroid Cancer

Type d’étude

Imagerie diagnostique

Nombre de patients à inclure

30

Investigateur(s)

   zerdoud.slimane@iuct-oncopole.fr;
   Elif.hindie@chu-bordeaux.fr;
   jaques.monteil@unilim.fr;
   David.taieb@ap-hm.fr;
   Marie-Claude.Eberle@icm.unicancer.fr

Centres

Bordeaux, Limoges, Marseille, Montpellier, Toulouse

Objectifs

The purpose of the study is to evaluate the impact and performance of a new PET / CT (computerized tomography ) tracer targeting dopamine receptor in patient with residual ganglionar biological disease after initial surgery of medullary thyroid cancer compared to standard imaging.

Relative rate of TRUE positive nodes with PET F-DOPA compared to standard imaging assessment. [ Time Frame: up to 3 years ]

Critères d’inclusion

•    Age > or = 18 years.
•    Patient with medullary thyroid cancer (sporadic or hereditary form).
•    Patient treated by total thyroidectomy with uni or bi-lateral lymph node dissection (in the central and/or lateral neck compartment).
•    Patient with elevated thyrocalcitonin rate > or = 150 pg/ml assessed within 6 weeks or more after surgery.
•    Patient with standard imaging assessment performed during 3 months before PET 18-FDOPA.
•    Standard imaging assessment including at least a cervical ultra-sound, a cervico-thoracic CT-scan and/or a cervico-thoraco-abdomino-pelvic CT-scan and a liver MRI.
•    Patient able to be followed at least 6 months after PET 18-FDOPA.
•    If women are breastfeeding, nursing should be discontinued during 24 hours after PET 18-FDOPA.
•    Patient must provide written informed consent prior to any specific procedure or assessment.
•    Patient must be affiliated to the French Social Security System.

Critères d’exclusion

•    Pregnant patient.
•    Post-operative radiotherapy initiated before PET 18-FDOPA.
•    Patient with PET 18-FDG performed within 24 hours before PET 18-FDOPA.
•    Participation in any other clinical trial for therapeutic use.
•    Patient with PET / CT-scan exam contra-indication.
•    Any serious and/or unstable pre-existing psychological, familial, geographic or social condition that could interfere with medical follow-up and compliance to study procedures.
•    Patient protected by law.