Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Whole-Body 3D T1-weighted MR Imaging Anatomical Sequences: GE mDixon vs FSE (View) Approaches in Prostate Cancer. (TFE-TVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03034070
Recruitment Status : Completed
First Posted : January 27, 2017
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Tracking Information
First Submitted Date  ICMJE January 17, 2017
First Posted Date  ICMJE January 27, 2017
Last Update Posted Date May 10, 2019
Study Start Date  ICMJE December 2016
Actual Primary Completion Date December 18, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2017)
Diagnostic performances of 3D GE T1 sub-sequences [ Time Frame: 3 months ]
Sensitivity, sensibility, positive and negative Predictive Values (PV) will be calculated with the results of each reading, and compared. The physical parameters of the different techniques will also be compared (Signal-to-noise ratio, contrast-to-noise ratio, ...).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Whole-Body 3D T1-weighted MR Imaging Anatomical Sequences: GE mDixon vs FSE (View) Approaches in Prostate Cancer.
Official Title  ICMJE Whole-Body 3D T1-weighted MR Imaging Anatomical Sequences: GE mDixon vs FSE (View) Approaches in Prostate Cancer. Comparison of Diagnostic Performance of GE mDixon and FSE, for Bone and Node Staging in Patients With Prostate Cancer.
Brief Summary This study will assess and compare the diagnostic performances and image quality of two WB 3D T1-weighted MR imaging sequences for bone and node staging in patients with prostate cancer : the FSE sequence and a gradient echo (GE) sequence. The latter sequence's main feature is its acquisition time of approximately 1.5 minutes, compared to 18 min for the FSE sequence, reducing the exam's acquisition time, patient discomfort and increasing machine availability.
Detailed Description

Whole-body (WB) magnetic resonance (MR) imaging has increasingly been used for the screening of bone and soft-tissue metastases in patients with prostate cancer (1). A limitation for its implementation is the 45-60 minutes duration of current WB MRI examinations. Conventional WB MR imaging studies consisted of anatomical two-dimensional (2D) T1-weighted and fat-suppressed fluid-sensitive (proton-density fat-saturated (PDFS) or short-tau inversion-recovery (STIR)) and of a functional diffusion-weighted imaging sequence. Recent research has confirmed the feasibility of replacing the 2D anatomical sequences by a single three-dimensional (3D) T1-weighted fast spin echo (FSE) sequence (2).

This study will assess and compare the diagnostic performances and image quality of two WB 3D T1-weighted MR imaging sequences for bone and node staging in patients with prostate cancer : the FSE sequence and a gradient echo (GE) sequence. The latter sequence's main feature is its acquisition time of approximately 1.5 minutes, compared to 18 min for the FSE sequence, reducing the exam's acquisition time, patient discomfort and increasing machine availability.

The aim of this study is to evaluate the feasibility of the replacement of the WB 3D T1-weighted FSE MR imaging sequence by the WB 3D T1-weighted GE MR imaging sequence.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Prostate Adenocarcinoma
  • Metastasis
Intervention  ICMJE Diagnostic Test: Diagnostic performance 3D T1
Although non-invasive, the prospective addition of a new MRI sequence to a routine MRI protocol is considered by our ethical committee as an "interventional" study.
Study Arms  ICMJE Diagnostic performance 3D T1
A 3D T1-weighted GE mDixon MR imaging sequence will be added to the routine 3D T1-weighted FSE sequence. mDixon sub-sequences (Fat and In Phase) are compared to 3D T1-weighted FSE in terms of diagnostic accuracy for M and N staging in prostate cancer patients: Fat, In Phase, Fat+In Phase and the routine 3D T1 will be analyzed separately, blindly and randomly.
Intervention: Diagnostic Test: Diagnostic performance 3D T1
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 25, 2017)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 1, 2019
Actual Primary Completion Date December 18, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • prostate cancer with high risk for metastases

Exclusion Criteria:

  • contraindications to MRI
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03034070
Other Study ID Numbers  ICMJE TFE TVE
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study Sponsor  ICMJE Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP