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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003927-12 | EudraCT Number |
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Through the investigators involvement in an international consortium, the investigators had the opportunity to acquire a new type of synthetizer for the radiolabelling of such tracers. The investigators propose in this project to develop on their site, the radiosynthesis of 68Ga-DOTATOC and to evaluate prospectively the diagnosis of neuroendocrine tumors, compared with the current imaging OctreoScan®. The objectives of this project are: - to validate the radiosynthesis of 68Ga-DOTATOC on their site with a new synthetizer - and clinically evaluate, through a prospective preliminary study, the diagnostic accuracy of PET-CT with 68Ga-DOTATOC in comparison with other standard imaging examinations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient who is suspected of endocrine tumors | Experimental | According to symptomatology, biology or imaging or pathological context |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-DOTATOC PET-CT Imaging | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of PET imaging | The diagnostic performance of PET-CT will be calculated and compared with other standard exams as the gold standard histology and clinical follow-up. | Inclusion (day 0) |
| Measure | Description | Time Frame |
|---|---|---|
| Reproducibility | The reproducibility of the new method of radiolabelling will be evaluated by the number of failed syntheses | Inclusion (day 0) |
| Tolerance | Tolerance of the tracer will be assessed by the collection of possible side effects |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe FERNANDEZ, Professor | University Hospital, Bordeaux | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux | Bordeaux | 33076 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26819103 | Result | Morgat C, Velayoudom-Cephise FL, Schwartz P, Guyot M, Gaye D, Vimont D, Schulz J, Mazere J, Nunes ML, Smith D, Hindie E, Fernandez P, Tabarin A. Evaluation of (68)Ga-DOTA-TOC PET/CT for the detection of duodenopancreatic neuroendocrine tumors in patients with MEN1. Eur J Nucl Med Mol Imaging. 2016 Jul;43(7):1258-66. doi: 10.1007/s00259-016-3319-3. Epub 2016 Jan 28. |
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| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Inclusion (day 0) and until end of follow up (day 28) |
| Impact on the therapeutic management | The impact on the therapeutic management of patients will be studied by the analysis of questionnaires with or without taking into account, the results of the PET-CT with 68Ga-DOTATOC. | End of follow up (day 28) |
| D009380 | Neoplasms, Nerve Tissue |