GALTEP: PET-CT Imaging of Neuro-endocrine Tumors and Preliminary Clinical Evaluation
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patient who is suspected of endocrine tumors According to symptomatology, biology or imaging or pathological context |
Procedure: 68Ga-DOTATOC PET-CT Imaging
|
Outcome Measures
Primary Outcome Measures
- Evaluation of PET imaging [Inclusion (day 0)]
The diagnostic performance of PET-CT will be calculated and compared with other standard exams as the gold standard histology and clinical follow-up.
Secondary Outcome Measures
- Reproducibility [Inclusion (day 0)]
The reproducibility of the new method of radiolabelling will be evaluated by the number of failed syntheses
- Tolerance [Inclusion (day 0) and until end of follow up (day 28)]
Tolerance of the tracer will be assessed by the collection of possible side effects
- Impact on the therapeutic management [End of follow up (day 28)]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients over 18 years
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Patient who is suspected of endocrine tumors according to symptomatology, biology or imaging or pathological context (multiple endocrine neoplasia type 1)
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initial staging: this includes research multifocal disease or locoregional or metastatic extension if well-differentiated neuroendocrine tumor (grade 1 et/ou 2)
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Search of the primary tumor, especially in the case of the inaugural discovery of metastases
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staging of a known recurrence
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Search occult recurrence or suspicion of recurrence (clinical, laboratory, imaging doubtful)
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Patient who have received in a lower range than 2 months of cervico-thoraco-abdominal-pelvic CT and scintigraphy in OctréoScan®
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Patient who have signed an informed consent
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Patient affiliated or beneficiary of regime of social security of a Member State of the European community
Exclusion Criteria:
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Patient with another evolutive cancer disease and/or treated for less than 5 years
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Pregnant or lactating woman
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Premenopausal woman without effective contraception (estrogen-progestin or intrauterine contraceptive device)
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Patient unable to give their free and informed consent
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Persons placed under judicial protection
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU de Bordeaux | Bordeaux | France | 33076 |
Sponsors and Collaborators
- University Hospital, Bordeaux
Investigators
- Principal Investigator: Philippe FERNANDEZ, Professor, University Hospital, Bordeaux
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CHUBX2012/28
- 2013-003927-12