TEP With 68-DOTANOC in Gastroenteropancreatic Neuroendocrine Tumors

Not Applicable

Completed

• Conditions: Patients With Gastroenteropancreatic Neuroendocrine Tumors
• Interventions: Drug: 68-Ga-DOTANOC

• Registration Number: NCT01747096
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-13
• Study First Submitted QC: 2012-12-10
• Study First Posted: 2012-12-11
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2016-07
• Last Update Submitted: 2022-01-06
• Last Update Posted: 2022-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68-Ga-DOTANOC	68-Ga-DOTANOC	-

Primary Outcome Measures

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

Name	Time	Method
Compare the diagnostic performance of PET / CT with 68Ga-DOTANOC with the standard process	12 months

Trial Locations

Locations (5)

Nantes Hospital; 🇫🇷 Saint Herblain, France

Hôpital Bichat; 🇫🇷 Paris, France

Hôpital Beaujon; 🇫🇷 Clichy, France

Institut de Cancérologie de l'Ouest, René Gauducheau; 🇫🇷 Saint Herblain, France

Angers Hospital; 🇫🇷 Angers, France