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TEP With 68-DOTANOC in Gastroenteropancreatic Neuroendocrine Tumors (68-DOTANOC-GEP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01747096
Recruitment Status : Completed
First Posted : December 11, 2012
Last Update Posted : July 29, 2016
Information provided by (Responsible Party):
Nantes University Hospital

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.

Condition or disease Intervention/treatment Phase
Patients With Gastroenteropancreatic Neuroendocrine Tumors Drug: 68-Ga-DOTANOC Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Compare the diagnostic performance of PET / CT with 68Ga-DOTANOC with the standard process [ Time Frame: 12 months ]

Other Outcome Measures:
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01747096

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Angers Hospital
Angers, France, 49100
Hôpital Beaujon
Clichy, France, 92110
Hôpital Bichat
Paris, France, 75018
Institut de Cancérologie de l'Ouest, René Gauducheau
Saint Herblain, France, 44805
Nantes Hospital
Saint Herblain, France, 44805
Sponsors and Collaborators
Nantes University Hospital
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Principal Investigator: Catherine Ansquer, MD Nantes Hospital
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Responsible Party: Nantes University Hospital Identifier: NCT01747096    
Other Study ID Numbers: BRD/11/05-K
First Posted: December 11, 2012    Key Record Dates
Last Update Posted: July 29, 2016
Last Verified: July 2016
Keywords provided by Nantes University Hospital:
Gastroenteropancreatic Neuroendocrine Tumors
immuno PET (iPET)
Gallium (68-Ga)
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Intestinal Neoplasms
Pancreatic Neoplasms
Stomach Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Stomach Diseases