PET-CT Imaging of Neuro-endocrine Tumors and Preliminary Clinical Evaluation

Study Overview
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Brief Summary
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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.

Official Title
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Development of an Innovative Gallium 68 Radiolabeling of DOTATOC (68Ga-DOTATOC) for PET-CT Imaging of Neuro-endocrine Tumors and Preliminary Clinical Evaluation

Conditions
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Neuroendocrine Tumors

Intervention / Treatment
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* Procedure: 68Ga-DOTATOC PET-CT Imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 18 years Patient who is suspected of endocrine tumors according to symptomatology, biology or imaging or pathological context (multiple endocrine neoplasia type 1) initial staging: this includes research multifocal disease or locoregional or metastatic extension if well-differentiated neuroendocrine tumor (grade 1 et/ou 2) Search of the primary tumor, especially in the case of the inaugural discovery of metastases staging of a known recurrence Search occult recurrence or suspicion of recurrence (clinical, laboratory, imaging doubtful) Patient who have received in a lower range than 2 months of cervico-thoraco-abdominal-pelvic CT and scintigraphy in OctréoScan® Patient who have signed an informed consent Patient affiliated or beneficiary of regime of social security of a Member State of the European community Exclusion Criteria: Patient with another evolutive cancer disease and/or treated for less than 5 years Pregnant or lactating woman Premenopausal woman without effective contraception (estrogen-progestin or intrauterine contraceptive device) Patient unable to give their free and informed consent Persons placed under judicial protection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient who is suspected of endocrine tumors<br>According to symptomatology, biology or imaging or pathological context | Procedure: 68Ga-DOTATOC PET-CT Imaging<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) |