Patients With Gastroenteropancreatic Neuroendocrine Tumors
Conditions
Keywords
Gastroenteropancreatic Neuroendocrine Tumors, immuno PET (iPET), Gallium (68-Ga), DOTANOC
Brief summary
Evaluation of the diagnostic performance of PET / CT with 68Ga-DOTANOC in Gastroenteropancreatic Neuroendocrine Tumors with comparison with other techniques used in routine clinical practice (octreoscan ® ; multiphase SPECT / CT, MRI or endoscopy). Therapeutic impact and safety of PET / CT with 68Ga-DOTANOC will also be assessed. Expected results are a confirmation of the superiority of 68Ga-PET DOTANOC versus scintigraphy octreoscan ®, with a potential impact on the therapeutic management of patients.
Interventions
DRUG68-Ga-DOTANOC
Sponsors
Nantes University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age over 18 years * effective contraception or exclusion of pregnancy dosage of beta-HCG in women of childbearing age * Fortuitous discovery of suggestive tumors of TE-GEP with well documented conventional imaging (multiphase CT; MRI, US endoscopy) associated or not associated with clinical or biological signs of TE-GEP tumors (increase in tumor markers) OR * Histologically proven GEP-TE (WHO classification 2010 (26) well differentiated in the initial staging OR * Suspicion of recurrence or progression of well differentiated TE-GEP tumors on conventional imaging or laboratory tests (increase in tumor markers) OR * Clinical or biological syndrome strongly suggestive of digestive endocrine disease without identification of lesions with conventional imaging * Informed consent and patient's written * Affiliation to an insurance
Exclusion criteria
* Multiple endocrine neoplasia * TE GEP tumor not differentiated * Pregnancy and lactation * Persons protected by law * Restlessness, inability to lie still hold at least 1 hour; Claustrophobia * Poor compliance predictable or inability to undergo medical test for geographical, social or psychological * Treatment with radiotherapy, chemotherapy or other antitumor treatment within 6 weeks of previous morphological and scintigraphic examinations. In case of treatment with somatostatin analogues delayed, scans will be performed 4 weeks after the last injection. However, a shorter period may be observed to avoid to do again the initial assessment exams. * malignancy except basal cell cancers and cancer in situ of the cervix * Contraindication of injection of a contrast agent necessary for the production of multiphase scanner. * Patients who had a CT scan without injection of contrast material can not participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection of Gastroenteropancreatic Neuroendocrine Tumors lesions in the initial assessment or during the search of recurrence. | 12 months | Reference to the gold standard (that will be obtained from the data of histology and / or follow-up imaging at least 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Compare the diagnostic performance of PET / CT with 68Ga-DOTANOC with the standard process | 12 months |
Other
| Measure | Time frame | Description |
|---|---|---|
| Assess the clinical impact of PET / CT 68 Ga-DOTANOC in terms of specificity and predictive value for the detection of locations of GEP. | 12 months | — |
| Assess the relevance of decisions of PET / CT 68 Ga-DOTANOC in terms of specificity and predictive value for the detection of locations of GEP. | 12 months | — |
| Assess the value of PET / CT 68 Ga-DOTANOC in terms of specificity and predictive value for the detection of locations of GEP. | 12 months | — |
| Tolerance of 68-Ga-DOTANOC | 12 mois | the vital signs and clinical tolerance will be assess during the 2 hours following injection of the radiopharmaceutical. |
Countries
France
Outcome results
None listed