Neuroendocrine Tumors
Conditions
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.
Interventions
PROCEDURE68Ga-DOTATOC PET-CT Imaging
Sponsors
University Hospital, Bordeaux
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORPhilippe FERNANDEZ, Professor
University Hospital, Bordeaux
Outcome results
None listed