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

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ClinicalTrials.gov Identifier: NCT03948841
Recruitment Status : Completed
First Posted : May 14, 2019
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

Tracking Information
First Submitted Date May 10, 2019
First Posted Date May 14, 2019
Last Update Posted Date May 14, 2019
Actual Study Start Date January 1, 2011
Actual Primary Completion Date December 1, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 10, 2019)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Measurement Variability of Liver Metastases From Neuroendocrine Tumors on Different Magnetic Resonance Imaging Sequences
Official Title Measurement Variability of Liver Metastases From Neuroendocrine Tumors on Different Magnetic Resonance Imaging Sequences
Brief 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.

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 Observational
Study Design Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with liver metastasis from neuroendocrine tumor with a magnetic resonance imaging in Reims university hospital.
Condition Neuroendocrine Tumors
Intervention Other: magnetic resonance imaging
Study Groups/Cohorts Neuroendocrine tumor
Patients with liver metastasis from neuroendocrine tumor
Intervention: Other: magnetic resonance imaging
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 10, 2019)
41
Original Actual Enrollment Same as current
Actual Study Completion Date September 1, 2016
Actual Primary Completion Date December 1, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03948841
Other Study ID Numbers 2018Ao006
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party CHU de Reims
Study Sponsor CHU de Reims
Collaborators Not Provided
Investigators Not Provided
PRS Account CHU de Reims
Verification Date May 2019