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

Medullary Thyroid Cancer Clinical Trial

— CMTpostopFDOPA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02856347
• Other study ID #: 16VADS03
• Status: Completed
• Phase: N/A
• Start date: March 22, 2017
• Est. completion date: December 20, 2020

Study information

• Verified date: March 2021
• Source: Institut Claudius Regaud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 20, 2020
• Est. primary completion date: December 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
France	CHU Haut-Lévêque	Bordeaux
France	CHU Limoges	Limoges
France	CHU Timone	Marseille
France	ICM Montpellier	Montpellier
France	Institut Claudius Regaud	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Institut Claudius Regaud

Country where clinical trial is conducted

France, 

Outcome

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