TEP With 68-DOTANOC in Gastroenteropancreatic Neuroendocrine Tumors

NCT ID: NCT01747096

Last Updated: 2022-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2016-05-31

Brief Summary

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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

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Conditions

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Patients With Gastroenteropancreatic Neuroendocrine Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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68-Ga-DOTANOC

Group Type EXPERIMENTAL

68-Ga-DOTANOC

Intervention Type DRUG

Interventions

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68-Ga-DOTANOC

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Catherine Ansquer, MD

Role: PRINCIPAL_INVESTIGATOR

Nantes Hospital

Locations

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Angers Hospital

Angers, , France

Site Status

Hôpital Beaujon

Clichy, , France

Site Status

Hôpital Bichat

Paris, , France

Site Status

Institut de Cancérologie de l'Ouest, René Gauducheau

Saint-Herblain, , France

Site Status

Nantes Hospital

Saint-Herblain, , France

Site Status

Countries

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France

Other Identifiers

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BRD/11/05-K

Identifier Type: -

Identifier Source: org_study_id

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