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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
CHU de Reims
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Neuroendocrine Tumors With Metastasis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 12, 2016
    Last Updated
    May 25, 2016
    Sponsor
    CHU de Reims
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    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

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

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