NCT02786303

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 12, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 1, 2016

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

June 1, 2016

Status Verified

May 1, 2016

Enrollment Period

2 years

First QC Date

May 12, 2016

Last Update Submit

May 25, 2016

Conditions

Neuroendocrine Tumors With Metastasis

Outcome Measures

Primary Outcomes (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

    Day 1

Study Arms (1)

arm whole-body MRI

OTHER
Device: Whole-body diffusion- weighted MRI

Interventions

Whole-body diffusion- weighted MRIDEVICE
arm whole-body MRI

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 31564038DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2016

First Posted

June 1, 2016

Study Start

April 1, 2014

Primary Completion

April 1, 2016

Study Completion

April 1, 2017

Last Updated

June 1, 2016

Record last verified: 2016-05