Clinical Trial · NCT03636945

Evaluation of 18F-FDOPA PET-CT in the Preoperative Initial Assessment of Medullary Thyroid Carcinoma

Overview

Medullary thyroid carcinoma (MTC) develops at the expense of calcitonin cells and is often characterized by lymph node metastases and sometimes visceral metastases. Improvement of preoperative diagnosis is of major importance in CMT because the quality of the initial surgery determines the prognosis. In recent years, 18F-fluorodihydroxyphenylalanine (18F-FDOPA) PET / CT was considered the most sensitive functional imaging tool in the evaluation of persistent CMT. To date, 18F-FDOPA PET at initial diagnosis has been reported in a few clinical cases. The main objective is to demonstrate that 18F-FDOPA PET provides additional information compared to conventional imaging on the initial diagnosis of CMT patients. The secondary objectives are to describe the nature of the information provided by PET / CT imaging, the main factors influencing tracer uptake and the positivity of PET / CT, and the impact of the examination on the care of the patient. This is a prospective, multicenter and open study. Patients with TCM who have serum calcitonin\> 150 pg / ml at initial diagnosis and have performed baseline imaging examinations within the last 3 months will be included in the study . A PET at 18F-FDOPA will be performed according to a very powerful acquisition protocol. Image analysis will be performed blindly from the results of conventional imaging. All exams will be compared, in accordance with the gold standard. Therapeutic intentions will be collected before and after the PET imaging, as well as the actual management in place.

Sponsor

Assistance Publique - Hôpitaux de Paris

Phase

N/A

Contacts

EMILIE GARRIDO PRADALIE (STUDY_DIRECTOR)

david TAIEB, MD (CONTACT)

david.taieb@ap-hm.fr

+33 491384706

ClinicalTrials.gov

NCT03636945

Drug / Compound

FDOPA

Isotope(s):
Target(s):
  • Aromatic L-amino acid decarboxylase (AADC)
Ligand Class: Small Molecules

Eligibility

Inclusion

  • Patients with CMT (initial diagnosis)
  • 150 \<Calcitonin \<500: cervical ultrasound + cervico-thoracic CT scan
  • Serum calcitonin\> 150 μg / ml
  • Calcitonin ≥500: cervical ultrasound, cervico-thoracoabdominopelvic CT scan, bone MRI.
  • Patient who had the baseline imaging assessment during the 3 months preceding the 18F-FDOPA PET scan (as recommended by the 2015 ATA (11)), according to the serum calcitonin level:
  • Major patient, affiliated to a social security scheme and having signed a written consent

Exclusion

  • Pregnant women (positive pregnancy test) or lactating women can not be included.