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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Patients With Gastroenteropancreatic Neuroendocrine Tumors

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Trial Information

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


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)

- 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Detection of Gastroenteropancreatic Neuroendocrine Tumors lesions in the initial assessment or during the search of recurrence.

Outcome Description:

Reference to the gold standard (that will be obtained from the data of histology and / or follow-up imaging at least 12 months

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Catherine Ansquer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Nantes Hospital

Authority:

France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:

BRD 11/5-K

NCT ID:

NCT01747096

Start Date:

November 2012

Completion Date:

November 2015

Related Keywords:

  • Patients With Gastroenteropancreatic Neuroendocrine Tumors
  • Gastroenteropancreatic Neuroendocrine Tumors
  • immuno PET (iPET)
  • Gallium (68-Ga)
  • DOTANOC
  • Neuroendocrine Tumors
  • Intestinal Neoplasms
  • Pancreatic Neoplasms
  • Stomach Neoplasms

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