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

Not Applicable

Completed

• Conditions: Medullary Thyroid Cancer
• Interventions: Other: 18F-DOPA

• Registration Number: NCT02856347
• Lead Sponsor: Institut Claudius Regaud

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-27
• Study First Submitted QC: 2016-08-01
• Study First Posted: 2016-08-04
• Study Start: 2017-03-22
• Primary Completion: 2020-12-20
• Study Completion: 2020-12-20
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-05
• Last Update Posted: 2021-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Age > or = 18 years.
2. Patient with medullary thyroid cancer (sporadic or hereditary form).
3. Patient treated by total thyroidectomy with uni or bi-lateral lymph node dissection (in the central and/or lateral neck compartment).
4. Patient with elevated thyrocalcitonin rate > or = 150 pg/ml assessed within 6 weeks or more after surgery.
5. Patient with standard imaging assessment performed during 3 months before PET 18-FDOPA.
6. 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.
7. Patient able to be followed at least 6 months after PET 18-FDOPA.
8. If women are breastfeeding, nursing should be discontinued during 24 hours after PET 18-FDOPA.
9. Patient must provide written informed consent prior to any specific procedure or assessment.
10. Patient must be affiliated to the French Social Security System.

Exclusion Criteria

1. Pregnant patient.
2. Post-operative radiotherapy initiated before PET 18-FDOPA.
3. Patient with PET 18-FDG performed within 24 hours before PET 18-FDOPA.
4. Participation in any other clinical trial for therapeutic use.
5. Patient with PET / CT-scan exam contra-indication.
6. 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.
7. Patient protected by law.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PET 18-FDOPA	18F-DOPA	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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 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.

Trial Locations

Locations (5)

CHU Haut-Lévêque; 🇫🇷 Bordeaux, France

CHU Limoges; 🇫🇷 Limoges, France

CHU Timone; 🇫🇷 Marseille, France

Institut Claudius Regaud; 🇫🇷 Toulouse, France

ICM Montpellier; 🇫🇷 Montpellier, France