TEP With 68-DOTANOC in Gastroenteropancreatic Neuroendocrine Tumors

Study Overview
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Brief Summary
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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.

Official Title
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Diagnostic, Prospective, Comparative, Multicentric Study of the PET / CT With 68Ga-DOTANOC Versus Conventional Imaging Procedures (octréoscan ® Scintigraphy and CT / MRI) in the Assessment of in Gastroenteropancreatic Neuroendocrine Tumors

Conditions
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Patients With Gastroenteropancreatic Neuroendocrine Tumors

Intervention / Treatment
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* Drug: 68-Ga-DOTANOC


Participation Criteria
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Eligibility Criteria
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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

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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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 68-Ga-DOTANOC<br> | Drug: 68-Ga-DOTANOC<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of Gastroenteropancreatic Neuroendocrine Tumors lesions in the initial assessment or during the search of recurrence. | Reference to the gold standard (that will be obtained from the data of histology and / or follow-up imaging at least 12 months | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the diagnostic performance of PET / CT with 68Ga-DOTANOC with the standard process |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastroenteropancreatic Neuroendocrine Tumors, immuno PET (iPET), Gallium (68-Ga), DOTANOC