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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 :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PET 18-FDOPA | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-DOPA | Other | Injection of 18F-DOPA and PET / CT-scan assessment |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Relative rate of FALSE positive nodes with PET F-DOPA compared to standard imaging assessment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Slimane Zerdoud, MD | Institut Claudius Regaud | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Haut-Lévêque | Bordeaux | France | ||||
| CHU Limoges |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42337037 | Result | Terroir M, Lusque A, Hindie E, Taieb D, Eberle-Pouzeratte MC, Verbeke S, Decote A, Grunenwald S, Zerdoud S. Prospective study on the [18F]FDOPA PET/CT role in the management of medullary thyroid cancer patients with high residual calcitonin level after surgery. Eur J Nucl Med Mol Imaging. 2026 Jun 24. doi: 10.1007/s00259-026-07992-2. Online ahead of print. |
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Analyses will be performed by patient and by node.
| up to 3 years |
| 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 |
| 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 |
| 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 |
| Limoges |
| France |
| CHU Timone | Marseille | France |
| ICM Montpellier | Montpellier | France |
| Institut Claudius Regaud | Toulouse | 31059 | France |
| ID | Term |
|---|---|
| D018276 | Carcinoma, Medullary |
| ID | Term |
|---|---|
| D018278 | Carcinoma, Neuroendocrine |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| C043437 | fluorodopa F 18 |
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