Overview

TEP With 68-DOTANOC in Gastroenteropancreatic Neuroendocrine Tumors

Status:
Completed
Trial end date:
2016-05-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Nantes University Hospital
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