TEP With 68-DOTANOC in Gastroenteropancreatic Neuroendocrine Tumors (68-DOTANOC-GEP)
This study is currently recruiting participants.
Verified November 2012 by Nantes University Hospital
Sponsor:
Nantes University Hospital
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01747096
First received: November 13, 2012
Last updated: February 19, 2013
Last verified: November 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Patients With Gastroenteropancreatic Neuroendocrine Tumors |
Drug: 68-Ga-DOTANOC |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official 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 |
Resource links provided by NLM:
Further study details as provided by Nantes University Hospital:
Primary Outcome Measures:
- Detection of Gastroenteropancreatic Neuroendocrine Tumors lesions in the initial assessment or during the search of recurrence. [ Time Frame: 12 months ] [ Designated as safety issue: No ]Reference to the gold standard (that will be obtained from the data of histology and / or follow-up imaging at least 12 months
Secondary Outcome Measures:
- Compare the diagnostic performance of PET / CT with 68Ga-DOTANOC with the standard process [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Other Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Tolerance of 68-Ga-DOTANOC [ Time Frame: 12 mois ] [ Designated as safety issue: Yes ]the vital signs and clinical tolerance will be assess during the 2 hours following injection of the radiopharmaceutical.
| Estimated Enrollment: | 90 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | November 2015 |
| Estimated Primary Completion Date: | November 2015 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01747096
Contacts
| Contact: Catherine Ansquer, MD | 0032 2 40 08 4136 | catherine.ansquer@chu-nantes.fr |
| Contact: Evelyne Scotet-Cérato, PhD | 00 32 253482840 | evelyne.cerato@chu-nantes.fr |
Locations
| France | |
| Angers Hospital | Recruiting |
| Angers, France, 49100 | |
| Contact: Oliiver Couturier, PhD, MD Olivier Couturier <ocouturier70@me.com> | |
| Contact: Evelyne Scotet-Cérato, PhD 0032253482840 evelyne.cerato@chu-nantes.fr | |
| Principal Investigator: Olivier Couturier, PhD, MD | |
| Sub-Investigator: Vincent Rohmer, PU, MD | |
| Insitutut de Cancérologie de l'Ouest, René Papin | Not yet recruiting |
| Angers, France, 49100 | |
| Contact: Olivier Morel, MD | |
| Contact: Evelyne Scotet-Cérato, PhD 0032253482840 evelyne.cerato@chu-nantes.fr | |
| Principal Investigator: Oliver Morel, MD | |
| Nantes Hospital | Recruiting |
| Saint Herblain, France, 44805 | |
| Contact: Catherine Ansquer, MD 0032240084136 catherine.ansquer@chu-nantes.fr | |
| Contact: Evelyne Scotet-Cérato, PhD, 0032253482840 evelyne.cerato@chu-nantes.fr | |
| Principal Investigator: Catherine Ansquer, MD | |
| Institut de Cancérologie de l'Ouest, René Gauducheau | Recruiting |
| Saint Herblain, France, 44805 | |
| Contact: Caroline Rousseau, PhD, MD 0032240679931 Rousseau Caroline <Caroline.Rousseau@ico.unicancer.fr> | |
| Contact: Evelyne Scotet-Cérato, PhD 0032253482840 evelyne.cerato@chu-nantes.fr | |
| Principal Investigator: Caroline Rousseau, PhD, MD | |
Sponsors and Collaborators
Nantes University Hospital
Investigators
| Principal Investigator: | Catherine Ansquer, MD | Nantes Hospital |
More Information
No publications provided
| Responsible Party: | Nantes University Hospital |
| ClinicalTrials.gov Identifier: | NCT01747096 History of Changes |
| Other Study ID Numbers: | BRD 11/5-K |
| Study First Received: | November 13, 2012 |
| Last Updated: | February 19, 2013 |
| Health Authority: | France: L’Agence nationale de sécurité du médicament et des produits de santé |
Keywords provided by Nantes University Hospital:
|
Gastroenteropancreatic Neuroendocrine Tumors immuno PET (iPET) Gallium (68-Ga) DOTANOC |
Additional relevant MeSH terms:
|
Neuroendocrine Tumors Intestinal Neoplasms Pancreatic Neoplasms Stomach Neoplasms Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Gastrointestinal Neoplasms |
Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Endocrine Gland Neoplasms Pancreatic Diseases Endocrine System Diseases Stomach Diseases |
ClinicalTrials.gov processed this record on May 21, 2013