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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01747096
Other study ID # BRD/11/05-K
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2012
Est. completion date May 2016

Study information

Verified date July 2016
Source Nantes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 130
Est. completion date May 2016
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
68-Ga-DOTANOC


Locations

Country Name City State
France 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

Sponsors (1)

Lead Sponsor Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Other Assess the clinical impact of PET / CT 68 Ga-DOTANOC in terms of specificity and predictive value for the detection of locations of GEP. 12 months
Other 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. 12 months
Other Assess the value of PET / CT 68 Ga-DOTANOC in terms of specificity and predictive value for the detection of locations of GEP. 12 months
Other Tolerance of 68-Ga-DOTANOC the vital signs and clinical tolerance will be assess during the 2 hours following injection of the radiopharmaceutical. 12 mois
Primary Detection of Gastroenteropancreatic Neuroendocrine Tumors lesions in the initial assessment or during the search of recurrence. Reference to the gold standard (that will be obtained from the data of histology and / or follow-up imaging at least 12 months 12 months
Secondary Compare the diagnostic performance of PET / CT with 68Ga-DOTANOC with the standard process 12 months