neuroendocrine tumors MedDRA version: 16.1 Level: PT Classification code 10052399 Term: Neuroendocrine tumour System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: DOTATOC marqué au Gallium 68
Product Code: 68Ga-DOTATOC
Pharmaceutical Form: Radiopharmaceutical precursor, solution
Sponsors
CHU de Bordeaux
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
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 |
|---|---|
| Main Objective: validate the radiosynthesis of 68Ga-DOTATOC on our 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.;Secondary Objective: Confirm the reproducibility of the synthesis of 68Ga-DOTATOC Confirm the perfect tolerance of 68Ga-DOTATOC. Estimate the clinical impact of the use of PET-CT with 68Ga-DOTATOC within the examinations of imaging by the rate of modification of the therapeutic attitude by the analysis of questionnaire;Primary end point(s): Diagnostic performance with 68Ga-DOTATOC PET-CT compared to standard examinations;Timepoint(s) of evaluation of this end point: Inclusion | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 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. Evaluate a potential change in the therapeutic attitude, induced by the results of 68Ga-DOTATOC PET-CT.;Timepoint(s) of evaluation of this end point: Inclusion | — |
Countries
France
Contacts
Public ContactLeila Boukami
CHU de Bordeaux
Outcome results
None listed