TEP With 68-DOTANOC in Gastroenteropancreatic Neuroendocrine Tumors (68-DOTANOC-GEP)
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|ClinicalTrials.gov Identifier: NCT01747096|
Recruitment Status : Completed
First Posted : December 11, 2012
Last Update Posted : July 29, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Patients With Gastroenteropancreatic Neuroendocrine Tumors||Drug: 68-Ga-DOTANOC||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official 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|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
- Detection of Gastroenteropancreatic Neuroendocrine Tumors lesions in the initial assessment or during the search of recurrence. [ Time Frame: 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
- Compare the diagnostic performance of PET / CT with 68Ga-DOTANOC with the standard process [ Time Frame: 12 months ]
- Assess the clinical impact of PET / CT 68 Ga-DOTANOC in terms of specificity and predictive value for the detection of locations of GEP. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 12 months ]
- Tolerance of 68-Ga-DOTANOC [ Time Frame: 12 mois ]the vital signs and clinical tolerance will be assess during the 2 hours following injection of the radiopharmaceutical.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01747096
|Angers, France, 49100|
|Clichy, France, 92110|
|Paris, France, 75018|
|Institut de Cancérologie de l'Ouest, René Gauducheau|
|Saint Herblain, France, 44805|
|Saint Herblain, France, 44805|
|Principal Investigator:||Catherine Ansquer, MD||Nantes Hospital|