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NCT03948841 Clinical Trial

Measurement Variability of Liver Metastases From Neuroendocrine Tumors on Different Magnetic Resonance Imaging Sequences

Neuroendocrine Tumors Clinical Trial

— NETMRI  

Official title:
Measurement Variability of Liver Metastases From Neuroendocrine Tumors on Different Magnetic Resonance Imaging Sequences

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03948841
Other study ID # 2018Ao006
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2011
Est. completion date September 1, 2016

Study information
Verified date May 2019
Source CHU de Reims
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of our study is to assess variability of measurements of liver metastases from neuroendocrine tumors (NET) on different magnetic resonance imaging (MRI) sequences.

In this institutional review board-approved retrospective study from January 2011 to December 2012, all liver MRIs performed at our department in patients with proven liver metastases from NETs and with at least one measurable lesion according to Response evaluation criteria in solid tumors (RECIST 1.1) were included.

Description:

The aim of our study is to assess variability of measurements of liver metastases from neuroendocrine tumors (NET) on different magnetic resonance imaging (MRI) sequences.

In this institutional review board-approved retrospective study from January 2011 to December 2012, all liver MRIs performed at our department in patients with proven liver metastases from NETs and with at least one measurable lesion according to Response evaluation criteria in solid tumors (RECIST 1.1) were included. Up to two lesions were selected by an independent radiologist on T2-weighted images and marked by an arrow. Three reviewers (attending radiologist R1, fellow R2, senior R3) independently obtained long axis measurements of 135 metastases in 30 patients, on T2, diffusion-weighted imaging (DWI) with three b values (50, 400, 800), arterial, portal and late phases after gadolinium ), and during two distant separate sessions. Intraclass correlation coefficients and Bland-Altman plots were used to assess intra-and interobserver variability.

Recruitment information / eligibility
Status Completed
Enrollment 41
Est. completion date September 1, 2016
Est. primary completion date December 1, 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility inclusion criteria :

- Patients with liver metastasis from neuroendocrine tumor

- Patients with a magnetic resonance imaging in Reims university hospital

- Patients with at least one measurable lesion according to Response evaluation criteria in solid tumors

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• magnetic resonance imaging

Locations
Country Name City State
France Damien JOLLY Reims

Sponsors (1)
Lead Sponsor Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

References & Publications (1)

Lestra T, Kanagaratnam L, Mulé S, Janvier A, Brixi H, Cadiot G, Dohan A, Hoeffel C. Measurement variability of liver metastases from neuroendocrine tumors on different magnetic resonance imaging sequences. Diagn Interv Imaging. 2018 Feb;99(2):73-81. doi: 10.1016/j.diii.2017.12.009. Epub 2018 Jan 12. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary variability of measurements of liver metastases from neuroendocrine tumors (NET) on different magnetic resonance imaging (MRI) sequences. calculation of intraclass correlation coefficient Day 0
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