Back to resultsProspective Study Evaluating the Medullary Thyroid Cancer Management's Care Using PET F-DOPA in Patients With a High Level of Postoperative Residual Thyrocalcitonin (CMTpostopFDOPA)
Primary Purpose
Medullary Thyroid Cancer
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
18F-DOPA
Sponsored by
About this trial
This is an interventional diagnostic trial for Medullary Thyroid Cancer focused on measuring Medullary Thyroid Cancer, PET F-DOPA, 18-FDOPA
Eligibility Criteria
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.
Sites / Locations
- CHU Haut-Lévêque
- CHU Limoges
- CHU Timone
- ICM Montpellier
- Institut Claudius Regaud
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
PET 18-FDOPA
Arm Description
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.
Outcomes
Primary Outcome Measures
Relative rate of TRUE positive nodes with PET F-DOPA compared to standard imaging assessment.
Analysis will be performed by node.
Secondary Outcome Measures
Relative rate of TRUE positive nodes with PET F-DOPA compared to standard imaging assessment.
Analysis will be performed by patient.
Relative rate of FALSE positive nodes with PET F-DOPA compared to standard imaging assessment.
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.
Analyses will be performed by patient and by metastasis.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02856347
Brief Title
Prospective Study Evaluating the Medullary Thyroid Cancer Management's Care Using PET F-DOPA in Patients With a High Level of Postoperative Residual Thyrocalcitonin
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
March 22, 2017 (Actual)
Primary Completion Date
December 20, 2020 (Actual)
Study Completion Date
December 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Claudius Regaud
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medullary Thyroid Cancer
Keywords
Medullary Thyroid Cancer, PET F-DOPA, 18-FDOPA
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PET 18-FDOPA
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
18F-DOPA
Intervention Description
Injection of 18F-DOPA and PET / CT-scan assessment
Primary Outcome Measure Information:
Title
Relative rate of TRUE positive nodes with PET F-DOPA compared to standard imaging assessment.
Description
Analysis will be performed by node.
Time Frame
up to 3 years
Secondary Outcome Measure Information:
Title
Relative rate of TRUE positive nodes with PET F-DOPA compared to standard imaging assessment.
Description
Analysis will be performed by patient.
Time Frame
up to 3 years
Title
Relative rate of FALSE positive nodes with PET F-DOPA compared to standard imaging assessment.
Description
Analyses will be performed by patient and by node.
Time Frame
up to 3 years
Title
Relative rate of TRUE positive and FALSE metastasis with PET F-DOPA compared to standard imaging assessment.
Description
Analyses will be performed by patient and by metastasis.
Time Frame
up to 3 years
Title
Modification rate of patient's care after PET F-DOPA exam.
Description
Comparison of the modification of care (orientation to a surgery or a surveillance) decided after standard imaging assessment following result of TEP-FDOPA exam.
Time Frame
up to 3 years
Title
The concordance between the PET F-DOPA results of each centre and centralized review.
Description
Concordance (centre / reviewer) of PET F-DOPA result interpretation will be evaluated.
Time Frame
up to 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Slimane Zerdoud, MD
Organizational Affiliation
Institut Claudius Regaud
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Haut-Lévêque
City
Bordeaux
Country
France
Facility Name
CHU Limoges
City
Limoges
Country
France
Facility Name
CHU Timone
City
Marseille
Country
France
Facility Name
ICM Montpellier
City
Montpellier
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse
ZIP/Postal Code
31059
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Prospective Study Evaluating the Medullary Thyroid Cancer Management's Care Using PET F-DOPA in Patients With a High Level of Postoperative Residual Thyrocalcitonin
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