Clinical trial NCT01747096: TEP With 68-DOTANOC in Gastroenteropancreatic Neuroendocrine Tumors
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
Overall status: COMPLETED
Phase: NA
Conditions: Patients With Gastroenteropancreatic Neuroendocrine Tumors
Keywords: Gastroenteropancreatic Neuroendocrine Tumors
immuno PET (iPET)
Gallium (68-Ga)
DOTANOC
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2012-12-11
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Detection of Gastroenteropancreatic Neuroendocrine Tumors lesions in the initial assessment or during the search of recurrence.
timeFrame: 12 months
Secondary outcomes:
measure: Compare the diagnostic performance of PET / CT with 68Ga-DOTANOC with the standard process
timeFrame: 12 months
Other outcomes:
measure: Assess the clinical impact of PET / CT 68 Ga-DOTANOC in terms of specificity and predictive value for the detection of locations of GEP.
timeFrame: 12 months
measure: 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.
timeFrame: 12 months
measure: Assess the value of PET / CT 68 Ga-DOTANOC in terms of specificity and predictive value for the detection of locations of GEP.
timeFrame: 12 months
measure: Tolerance of 68-Ga-DOTANOC
timeFrame: 12 mois
Locations:
city: Angers
country: France
facility: Angers Hospital
city: Clichy
country: France
facility: Hôpital Beaujon
city: Paris
country: France
facility: Hôpital Bichat
city: Saint Herblain
country: France
facility: Institut de Cancérologie de l'Ouest, René Gauducheau
city: Saint Herblain
country: France
facility: Nantes Hospital
Study officials:
affiliation: Nantes Hospital
name: Catherine Ansquer, MD
role: PRINCIPAL_INVESTIGATOR
References: