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TEP With 68-DOTANOC in Gastroenteropancreatic Neuroendocrine Tumors (68-DOTANOC-GEP)

N

Nantes University Hospital (NUH)

Status

Completed

Conditions

Patients With Gastroenteropancreatic Neuroendocrine Tumors

Treatments

Drug: 68-Ga-DOTANOC

Study type

Interventional

Funder types

Other

Identifiers

NCT01747096
BRD/11/05-K

Details and patient eligibility

About

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.

Enrollment

130 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

130 participants in 1 patient group

68-Ga-DOTANOC
Experimental group
Treatment:
Drug: 68-Ga-DOTANOC

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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