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

NCT02856347 | Completed

• 1 other identifier: 16VADS03
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 5

Brief Summary

The aim of the trial is to study a radiating diagnosis agent used in post surgery when the biological assessment highlighted a residual disease. This is an inter-regional multicentric, prospective study evaluating the benefit of PET F-DOPA imaging in involved node detection compared to standard imaging assessment in patient with medullary thyroid cancer. 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. Obtained data will be compared to the "gold standard" based on :

• nodes cytology when they could be punctured
• histology when a new surgery will be recommended
• surveillance when the 2 first cases will be not applicable (imaging monitoring, evolution of thyrocalcitonin)

Conditions

Medullary Thyroid Cancer

Keywords

Medullary Thyroid Cancer; PET F-DOPA; 18-FDOPA

Outcome Measures

Primary Outcomes (1)

• Relative rate of TRUE positive nodes with PET F-DOPA compared to standard imaging assessment.

  Analysis will be performed by node.

  up to 3 years

Secondary Outcomes (5)

• Relative rate of TRUE positive nodes with PET F-DOPA compared to standard imaging assessment.

  up to 3 years

• Relative rate of FALSE positive nodes with PET F-DOPA compared to standard imaging assessment.

  up to 3 years

• Relative rate of TRUE positive and FALSE metastasis with PET F-DOPA compared to standard imaging assessment.

  up to 3 years

• Modification rate of patient's care after PET F-DOPA exam.

  up to 3 years

• The concordance between the PET F-DOPA results of each centre and centralized review.

  up to 3 years

Study Arms (1)

PET 18-FDOPA

OTHER

18F-DOPA will be administered with an activity of 1.5-4 MBq/kg (MegaBecquerel) in the IV (Intra venous) tubing to decrease the extravasation risk and tracer lymphatic migration. The injection site will be distant from pathologic area (forearm). PET CT exam will start 10 min after tracer injection and will cover the whole body (10 to 30 min). Other series of images will be done 50 min after tracer injection. Images will be interpreted.

Other: 18F-DOPA

Interventions

18F-DOPA OTHER

Injection of 18F-DOPA and PET / CT-scan assessment

PET 18-FDOPA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Claudius Regaud: lead

Study Sites (5)

CHU Haut-Lévêque

Bordeaux, France

Location

CHU Limoges

Limoges, France

Location

CHU Timone

Marseille, France

Location

ICM Montpellier

Montpellier, France

Location

Institut Claudius Regaud

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Carcinoma, Medullary

Interventions

fluorodopa F 18

Condition Hierarchy (Ancestors)

Carcinoma, Neuroendocrine; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms, Nerve Tissue

Study Officials

• Slimane Zerdoud, MD

  Institut Claudius Regaud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2016
• First Posted: August 4, 2016
• Study Start: March 22, 2017
• Primary Completion: December 20, 2020
• Study Completion: December 20, 2020
• Last Updated: November 18, 2025

Record last verified: 2025-07

Locations

FR (5)