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

NCT ID: NCT03636945

Last Updated: 2018-08-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-31
• Study Completion Date: 2021-09-30

Brief Summary

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.

Detailed Description

Medullary thyroid carcinoma (MTC) develops at the expense of calcitonin cells and is often characterized by lymph node metastases (> 50% of cases) and sometimes visceral metastases (> 5%). 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. Preliminary study, which included 9 CMT patients, 18F-FDOPA PET showed very promising results during the initial diagnosis, particularly in node staging.

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 (as recommended by the 2015 ATA) 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.

Number of patients expected: 62. Duration of the study: 29 months of inclusion and 7 months of follow-up.

About 60 to 70 patients with a CMT are operated annually in the centers involved. Nuclear physicians, endocrine surgeons, endocrinologists and anatomopathologists work together in institutional and interinstitutional team meetings (SFE-RENATEN). Some of the centers have already collaborated on the implementation of a large PHRC-INCa project recently published in the JCEM.

Conditions

Medullary Thyroid Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Medullary thyroid carcinoma

Patients with MTC 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

Group Type: EXPERIMENTAL

PET at 18F-FDOPA

Intervention Type: OTHER

18F-fluorodihydroxyphenylalanine (18F-FDOPA) PET imaging

Interventions

PET at 18F-FDOPA

18F-fluorodihydroxyphenylalanine (18F-FDOPA) PET imaging

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Major patient, affiliated to a social security scheme and having signed a written consent
• Patients with CMT (initial diagnosis)
• Serum calcitonin> 150 μg / ml
• 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:

• 150 <Calcitonin <500: cervical ultrasound + cervico-thoracic CT scan
• Calcitonin ≥500: cervical ultrasound, cervico-thoracoabdominopelvic CT scan, bone MRI.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

EMILIE GARRIDO PRADALIE

Role: STUDY_DIRECTOR

APHM

Locations

Assistance Publique Des Hopitaux de Marseille

Marseille, PACA, France

Countries

France

Central Contacts

david TAIEB, MD

Role: CONTACT

David.TAIEB@ap-hm.fr

+33 491384706

Other Identifiers

2018-10

Identifier Type: -

Identifier Source: org_study_id