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

Primary Purpose

Patients With Gastroenteropancreatic Neuroendocrine Tumors

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
68-Ga-DOTANOC
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Patients With Gastroenteropancreatic Neuroendocrine Tumors focused on measuring Gastroenteropancreatic Neuroendocrine Tumors, immuno PET (iPET), Gallium (68-Ga), DOTANOC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Angers Hospital
  • Hôpital Beaujon
  • Hôpital Bichat
  • Institut de Cancérologie de l'Ouest, René Gauducheau
  • Nantes Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

68-Ga-DOTANOC

Arm Description

Outcomes

Primary Outcome Measures

Detection of Gastroenteropancreatic Neuroendocrine Tumors lesions in the initial assessment or during the search of recurrence.
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

Full Information

First Posted
November 13, 2012
Last Updated
January 6, 2022
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01747096
Brief Title
TEP With 68-DOTANOC in Gastroenteropancreatic Neuroendocrine Tumors
Acronym
68-DOTANOC-GEP
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 Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Gastroenteropancreatic Neuroendocrine Tumors
Keywords
Gastroenteropancreatic Neuroendocrine Tumors, immuno PET (iPET), Gallium (68-Ga), DOTANOC

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
68-Ga-DOTANOC
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
68-Ga-DOTANOC
Primary Outcome Measure Information:
Title
Detection of Gastroenteropancreatic Neuroendocrine Tumors lesions in the initial assessment or during the search of recurrence.
Description
Reference to the gold standard (that will be obtained from the data of histology and / or follow-up imaging at least 12 months
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Compare the diagnostic performance of PET / CT with 68Ga-DOTANOC with the standard process
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
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
Title
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
Title
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
Title
Tolerance of 68-Ga-DOTANOC
Description
the vital signs and clinical tolerance will be assess during the 2 hours following injection of the radiopharmaceutical.
Time Frame
12 mois

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Ansquer, MD
Organizational Affiliation
Nantes Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Angers Hospital
City
Angers
ZIP/Postal Code
49100
Country
France
Facility Name
Hôpital Beaujon
City
Clichy
ZIP/Postal Code
92110
Country
France
Facility Name
Hôpital Bichat
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Institut de Cancérologie de l'Ouest, René Gauducheau
City
Saint Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Nantes Hospital
City
Saint Herblain
ZIP/Postal Code
44805
Country
France

12. IPD Sharing Statement

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TEP With 68-DOTANOC in Gastroenteropancreatic Neuroendocrine Tumors

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