Interest of Whole-body MRI Correlated to Spreading Sequences for Staging Neuroendocrine Tumors (LAB-2013-01)
Primary Purpose
Neuroendocrine Tumors With Metastasis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Whole-body diffusion- weighted MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Neuroendocrine Tumors With Metastasis
Eligibility Criteria
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:
-
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
arm whole-body MRI
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02786303
Brief Title
Interest of Whole-body MRI Correlated to Spreading Sequences for Staging Neuroendocrine Tumors
Acronym
LAB-2013-01
Official Title
Interest of Whole-body MRI Correlated to Spreading Sequences for Staging
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Tumors With Metastasis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
arm whole-body MRI
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Whole-body diffusion- weighted MRI
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
-
12. IPD Sharing Statement
Citations:
PubMed Identifier
31564038
Citation
Minon M, Soriano C, Morland D, Walter T, Lepage C, Tabarin A, Deblock M, Rousset P, Barbe C, Hoeffel C, Cadiot G. Prospective comparison of whole-body MRI with diffusion-weighted and conventional imaging for the follow-up of neuroendocrine tumors. Endocrine. 2020 Jan;67(1):243-251. doi: 10.1007/s12020-019-02095-5. Epub 2019 Sep 28.
Results Reference
derived
Learn more about this trial
Interest of Whole-body MRI Correlated to Spreading Sequences for Staging Neuroendocrine Tumors
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