NCT Number: NCT01747096
TEP With 68-DOTANOC in Gastroenteropancreatic Neuroendocrine Tumors
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.
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Notify MeKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Angers Hospital, Angers, France
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Detection of Gastroenteropancreatic Neuroendocrine Tumors lesions in the initial assessment or during the search of recurrence.
Time frame: 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 outcomes
-
Compare the diagnostic performance of PET / CT with 68Ga-DOTANOC with the standard process
Time frame: 12 months
Other outcomes
-
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
-
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
-
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
-
Tolerance of 68-Ga-DOTANOC
Time frame: 12 mois
the vital signs and clinical tolerance will be assess during the 2 hours following injection of the radiopharmaceutical.
Sponsors and collaborators
Lead sponsor
Nantes University Hospital
Other
Registry information
Official study 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
Acronym: 68-DOTANOC-GEP
Important dates
- Study start
- 2012
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Dec 11, 2012
- Registry last updated
- Jan 21, 2022
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.