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

May 25, 2016 updated by: CHU de Reims

Interest of Whole-body MRI Correlated to Spreading Sequences for Staging

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: arm whole-body MRI
Device: Whole-body diffusion- weighted MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Reims

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

April 1, 2016

Study Completion (Anticipated)

April 1, 2017

Study Registration Dates

First Submitted

May 12, 2016

First Submitted That Met QC Criteria

May 25, 2016

First Posted (Estimate)

June 1, 2016

Study Record Updates

Last Update Posted (Estimate)

June 1, 2016

Last Update Submitted That Met QC Criteria

May 25, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI13103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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