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TEP With 68-DOTANOC in Gastroenteropancreatic Neuroendocrine Tumors | Clinical Trials | Clareo Health

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TEP With 68-DOTANOC in Gastroenteropancreatic Neuroendocrine Tumors

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

NCT01747096•Nantes University Hospital

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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

Locations (5)

Angers Hospital

Angers, France

Hôpital Beaujon

Clichy, France

Hôpital Bichat

Paris, France

Institut de Cancérologie de l'Ouest, René Gauducheau

Saint-Herblain, France

Nantes Hospital

Saint-Herblain, France

Key Dates

Start Date

November 1, 2012

Primary Completion Date

May 1, 2016

Completion Date

May 1, 2016

Last Updated

January 21, 2022

Enrollment

130

ACTUAL participants

Conditions

Patients With Gastroenteropancreatic Neuroendocrine Tumors

Interventions

68-Ga-DOTANOC

DRUG