- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03948841
Measurement Variability of Liver Metastases From Neuroendocrine Tumors on Different Magnetic Resonance Imaging Sequences (NETMRI)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Reims, France
- Damien JOLLY
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Neuroendocrine tumor
Patients with liver metastasis from neuroendocrine tumor
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
variability of measurements of liver metastases from neuroendocrine tumors (NET) on different magnetic resonance imaging (MRI) sequences.
Time Frame: Day 0
|
calculation of intraclass correlation coefficient
|
Day 0
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018Ao006
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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