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

Medullary Thyroid Carcinoma Clinical Trial

— TEPCMT  

Official title:

Evaluation of the Clinical Performance of 18F-FDOPA PET-CT in the Preoperative Initial Assessment of Medullary Thyroid Carcinoma: Multicenter Prospective Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03636945
• Other study ID #: 2018-10
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2018
• Est. completion date: September 2021

Study information

• Verified date: August 2018
• Source: Assistance Publique Hopitaux De Marseille
• Contact: david TAIEB, MD
• Phone: +33 491384706
• Email: David.TAIEB[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 62
• Est. completion date: September 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Neuroendocrine
• Medullary Thyroid Carcinoma
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Other:
• PET at 18F-FDOPA
18F-fluorodihydroxyphenylalanine (18F-FDOPA) PET imaging

Locations

Country	Name	City	State
France	Assistance Publique Des Hopitaux de Marseille	Marseille	Paca

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patient with aditionnal information	the proportion of CMT patients for whom 18F-FDOPA PET / CT PET provides additional information compared to the conventional imaging (CI) assessment at the initial diagnosis.	90 MINUTES