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

January 6, 2022 updated by: Nantes University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49100
        • Angers Hospital
      • Clichy, France, 92110
        • Hopital Beaujon
      • Paris, France, 75018
        • Hôpital Bichat
      • Saint Herblain, France, 44805
        • Institut de Cancérologie de l'Ouest, René Gauducheau
      • Saint Herblain, France, 44805
        • Nantes Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 68-Ga-DOTANOC
Drug: 68-Ga-DOTANOC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Compare the diagnostic performance of PET / CT with 68Ga-DOTANOC with the standard process
Time Frame: 12 months
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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.
12 mois

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

  • Principal Investigator: Catherine Ansquer, MD, Nantes Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

November 13, 2012

First Submitted That Met QC Criteria

December 10, 2012

First Posted (Estimate)

December 11, 2012

Study Record Updates

Last Update Posted (Actual)

January 21, 2022

Last Update Submitted That Met QC Criteria

January 6, 2022

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRD/11/05-K

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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