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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01747096
First received: November 13, 2012
Last updated: June 19, 2014
Last verified: April 2014
  Purpose

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 Intervention
Patients With Gastroenteropancreatic Neuroendocrine Tumors
Drug: 68-Ga-DOTANOC

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Detection of Gastroenteropancreatic Neuroendocrine Tumors lesions in the initial assessment or during the search of recurrence. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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:
  • Compare the diagnostic performance of PET / CT with 68Ga-DOTANOC with the standard process [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Tolerance of 68-Ga-DOTANOC [ Time Frame: 12 mois ] [ Designated as safety issue: Yes ]
    the vital signs and clinical tolerance will be assess during the 2 hours following injection of the radiopharmaceutical.


Estimated Enrollment: 130
Study Start Date: November 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01747096

Contacts
Contact: Catherine Ansquer, MD 0032 2 40 08 4136 catherine.ansquer@chu-nantes.fr
Contact: Evelyne Scotet-Cérato, PhD 00 32 253482840 evelyne.cerato@chu-nantes.fr

Locations
France
Angers Hospital Recruiting
Angers, France, 49100
Contact: Oliiver Couturier, PhD, MD       Olivier Couturier <ocouturier70@me.com>   
Contact: Evelyne Scotet-Cérato, PhD    0032253482840    evelyne.cerato@chu-nantes.fr   
Principal Investigator: Olivier Couturier, PhD, MD         
Sub-Investigator: Vincent Rohmer, PU, MD         
Insitutut de Cancérologie de l'Ouest, René Papin Not yet recruiting
Angers, France, 49100
Contact: Olivier Morel, MD         
Contact: Evelyne Scotet-Cérato, PhD    0032253482840    evelyne.cerato@chu-nantes.fr   
Principal Investigator: Oliver Morel, MD         
Hôpital Beaujon Not yet recruiting
Clichy, France, 92110
Contact: Evelyne Scotet-Cérato, PhD         
Principal Investigator: Rachida Labtahi, MD         
Hôpital Bichat Not yet recruiting
Paris, France, 75018
Contact: Evelyne Scotet-Cérato, PhD         
Principal Investigator: Dominique Leguludec, MD         
Institut de Cancérologie de l'Ouest, René Gauducheau Recruiting
Saint Herblain, France, 44805
Contact: Caroline Rousseau, PhD, MD    0032240679931    Rousseau Caroline <Caroline.Rousseau@ico.unicancer.fr>   
Contact: Evelyne Scotet-Cérato, PhD    0032253482840    evelyne.cerato@chu-nantes.fr   
Principal Investigator: Caroline Rousseau, PhD, MD         
Nantes Hospital Recruiting
Saint Herblain, France, 44805
Contact: Catherine Ansquer, MD    0032240084136    catherine.ansquer@chu-nantes.fr   
Contact: Evelyne Scotet-Cérato, PhD,    0032253482840    evelyne.cerato@chu-nantes.fr   
Principal Investigator: Catherine Ansquer, MD         
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Catherine Ansquer, MD Nantes Hospital
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01747096     History of Changes
Other Study ID Numbers: BRD 11/5-K
Study First Received: November 13, 2012
Last Updated: June 19, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Nantes University Hospital:
Gastroenteropancreatic Neuroendocrine Tumors
immuno PET (iPET)
Gallium (68-Ga)
DOTANOC

Additional relevant MeSH terms:
Neuroendocrine Tumors
Intestinal Neoplasms
Pancreatic Neoplasms
Stomach Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Endocrine System Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on July 24, 2014