Prospective Study Evaluating the Medullary Thyroid Cancer Management's Care Using PET F-DOPA in Patients With a High Level of Postoperative Residual Thyrocalcitonin (CMTpostopFDOPA)
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|ClinicalTrials.gov Identifier: NCT02856347|
Recruitment Status : Recruiting
First Posted : August 4, 2016
Last Update Posted : August 8, 2019
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||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 :||March 22, 2017|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||April 2021|
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.
Injection of 18F-DOPA and PET / CT-scan assessment
- Relative rate of TRUE positive nodes with PET F-DOPA compared to standard imaging assessment. [ Time Frame: up to 3 years ]Analysis will be performed by node.
- Relative rate of TRUE positive nodes with PET F-DOPA compared to standard imaging assessment. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: up to 3 years ]Analyses will be performed by patient and by metastasis.
- Modification rate of patient's care after PET F-DOPA exam. [ Time Frame: 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. [ Time Frame: up to 3 years ]Concordance (centre / reviewer) of PET F-DOPA result interpretation will be evaluated.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02856347
|Contact: Slimane Zerdoud, MD||0033 05 31 15 56 email@example.com|
|Contact: Elif Hindie, MD +33 05 57 65 64 08 Elif.firstname.lastname@example.org|
|Principal Investigator: Elif Hindie, MD|
|Contact: Jacques Monteil, MD email@example.com|
|Principal Investigator: Jacques Monteil, MD|
|Contact: David Taïeb, MD +33 04 91 38 44 06 David.firstname.lastname@example.org|
|Principal Investigator: David Taïeb, MD|
|Contact: Marie-Claude Eberle, MD +33 04 67 61 85 82 Marie-Claude.Eberle@icm.unicancer.fr|
|Principal Investigator: Marie-Claude Eberle, MD|
|Institut Claudius Regaud||Recruiting|
|Toulouse, France, 31059|
|Contact: Slimane Zerdoud, MD +33 5 31 15 52 70 email@example.com|
|Principal Investigator: Slimane Zerdoud, MD|
|Principal Investigator:||Slimane Zerdoud, MD||Institut Claudius Regaud|