Patients With Gastroenteropancreatic Neuroendocrine Tumors Clinical Trial
— 68-DOTANOC-GEPOfficial title:
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
| NCT number | NCT01747096 |
| Other study ID # | BRD/11/05-K |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | November 2012 |
| Est. completion date | May 2016 |
| Verified date | July 2016 |
| Source | Nantes University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 130 |
| Est. completion date | May 2016 |
| Est. primary completion date | May 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Angers Hospital | Angers | |
| France | Hôpital Beaujon | Clichy | |
| France | Hôpital Bichat | Paris | |
| France | Institut de Cancérologie de l'Ouest, René Gauducheau | Saint Herblain | |
| France | Nantes Hospital | Saint Herblain |
| Lead Sponsor | Collaborator |
|---|---|
| Nantes University Hospital |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | 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 | ||
| Other | 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 | ||
| Other | 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 | ||
| Other | Tolerance of 68-Ga-DOTANOC | the vital signs and clinical tolerance will be assess during the 2 hours following injection of the radiopharmaceutical. | 12 mois | |
| Primary | 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 | Compare the diagnostic performance of PET / CT with 68Ga-DOTANOC with the standard process | 12 months |