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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
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Tracking Information
First Submitted Date  ICMJE November 13, 2012
First Posted Date  ICMJE December 11, 2012
Last Update Posted Date July 29, 2016
Study Start Date  ICMJE November 2012
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2012)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01747096 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2012)
Compare the diagnostic performance of PET / CT with 68Ga-DOTANOC with the standard process [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 10, 2012)
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE TEP With 68-DOTANOC in Gastroenteropancreatic Neuroendocrine Tumors
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Patients With Gastroenteropancreatic Neuroendocrine Tumors
Intervention  ICMJE Drug: 68-Ga-DOTANOC
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: June 19, 2014)
130
Original Estimated Enrollment  ICMJE
 (submitted: December 10, 2012)
90
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01747096
Other Study ID Numbers  ICMJE BRD/11/05-K
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nantes University Hospital
Study Sponsor  ICMJE Nantes University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Catherine Ansquer, MD Nantes Hospital
PRS Account Nantes University Hospital
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP