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

Sponsor

Institut Claudius Regaud (Other)

Overall Status

Completed

CT.gov ID

NCT02856347

Collaborator

(none)

Enrollment

Locations

Arm

Actual Duration (Months)

4.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Medullary Thyroid Cancer	Other: 18F-DOPA	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Mar 22, 2017

Actual Primary Completion Date :

Dec 20, 2020

Actual Study Completion Date :

Dec 20, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: PET 18-FDOPA 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 Injection of 18F-DOPA and PET / CT-scan assessment

Arm

Intervention/Treatment

Other: PET 18-FDOPA

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

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

Outcome Measures

Primary Outcome Measures

Relative rate of TRUE positive nodes with PET F-DOPA compared to standard imaging assessment. [up to 3 years]
Analysis will be performed by node.

Secondary Outcome Measures

Relative rate of TRUE positive nodes with PET F-DOPA compared to standard imaging assessment. [up to 3 years]
Analysis will be performed by patient.
Relative rate of FALSE positive nodes with PET F-DOPA compared to standard imaging assessment. [up to 3 years]
Analyses will be performed by patient and by node.
Relative rate of TRUE positive and FALSE metastasis with PET F-DOPA compared to standard imaging assessment. [up to 3 years]
Analyses will be performed by patient and by metastasis.
Modification rate of patient's care after PET F-DOPA exam. [up to 3 years]
Comparison of the modification of care (orientation to a surgery or a surveillance) decided after standard imaging assessment following result of TEP-FDOPA exam.
The concordance between the PET F-DOPA results of each centre and centralized review. [up to 3 years]
Concordance (centre / reviewer) of PET F-DOPA result interpretation will be evaluated.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	CHU Haut-Lévêque	Bordeaux	France
2	CHU Limoges	Limoges	France
3	CHU Timone	Marseille	France
4	ICM Montpellier	Montpellier	France
5	Institut Claudius Regaud	Toulouse	France	31059