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Interest of Whole-body MRI Correlated to Spreading Sequences for Staging Neuroendocrine Tumors (LAB-2013-01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02786303
Recruitment Status : Unknown
Verified May 2016 by CHU de Reims.
Recruitment status was:  Active, not recruiting
First Posted : June 1, 2016
Last Update Posted : June 1, 2016
Information provided by (Responsible Party):
CHU de Reims

Brief Summary:
The diagnosis and the follow-up of neuroendocrine tumors can be difficult to assess, especially in the detection of metastasis as they can grow in different organs such as liver, lungs, bones or lymph nodes. Nowadays, the diagnosis is made with two main imaging techniques which are the thoraco-abdomino-pelvic CT-scan and a scintigraphic method (Octreoscan and sometimes a TEP-scan). The use of a whole-body MRI is more and more often used for the detection and evaluation of tumors and metastases; therefore, it could be used for neuroendocrine tumors. The MRI would allow to replace the two imaging techniques and to avoid the use of irradiation but also to have a better detection of metastases. This purpose of the study was to evaluate this statement by assessing the consistency between the routine techniques and the MRI and finally to update the recommendation if the study is positive.

Condition or disease Intervention/treatment Phase
Neuroendocrine Tumors With Metastasis Device: Whole-body diffusion- weighted MRI Not Applicable

Detailed Description:
The main metastatic sites of neuroendocrine tumors can be the liver, the bones, the lungs and lymph nodes. According to the French recommendations (" Thesaurus national de cancérologie digestive "), the initial assessment includes a thoraco-abdomino-pelvic CT-scan and a scintigraphic method (Octreoscan and TEP-scan if Octreoscan negative). The aim is to detect metastases and tumoral progression to offer the appropriate treatment, such as surgery. Due to its high contrast resolution, its absence of irradiation, and diffusion sequences, the MRI is more and more used to detect tumor progression. The recent literature shows better results with the diffusion sequences than the T2-weighted sequences and, potentially, than the contrast-enhanced sequences to detect liver metastasis. The whole-body diffusion-weighted MRI seems promising for the staging and the following of some cancers. Only two publications have evaluated the diagnostic value of diffusion sequences to detect pancreatic neuroendocrine tumors and liver metastasis. Yet, no publication has assessed the diagnostic value of whole-body diffusion-weighted MRI in the patients with neuroendocrine tumors.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Interest of Whole-body MRI Correlated to Spreading Sequences for Staging
Study Start Date : April 2014
Actual Primary Completion Date : April 2016
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
arm whole-body MRI Device: Whole-body diffusion- weighted MRI

Primary Outcome Measures :
  1. Correspondance between whole-body diffusion-weighted MRI and thoraco-abdomino-pelvic CT-scan associated with a scintigraphic method in the detection and staging of neuroendocrine tumors and metastases [ Time Frame: Day 1 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with moderately to well-differentiated neuroendocrine tumors with stage ≥ 3 according to the classification ENETS, regardless the tumor site and the OMS
  • Patients who signed the informed consent
  • Patients followed in one of the participating center

Exclusion Criteria:


Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: CHU de Reims Identifier: NCT02786303    
Other Study ID Numbers: PI13103
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: June 1, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue