Whole-Body 3D T1-weighted MR Imaging Anatomical Sequences: GE mDixon vs FSE (View) Approaches in Prostate Cancer.
TFE-TVE
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 17, 2017
CompletedFirst Posted
Study publicly available on registry
January 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 18, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedMay 10, 2019
May 1, 2019
1 year
January 17, 2017
May 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Diagnostic performances of 3D GE T1 sub-sequences
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, ...).
3 months
Study Arms (1)
Diagnostic performance 3D T1
OTHERA 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- prostate cancer with high risk for metastases
You may not qualify if:
- contraindications to MRI
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cliniques universitaires Saint-Luc
Brussels, 1200, Belgium
Related Publications (2)
Lecouvet FE, El Mouedden J, Collette L, Coche E, Danse E, Jamar F, Machiels JP, Vande Berg B, Omoumi P, Tombal B. Can whole-body magnetic resonance imaging with diffusion-weighted imaging replace Tc 99m bone scanning and computed tomography for single-step detection of metastases in patients with high-risk prostate cancer? Eur Urol. 2012 Jul;62(1):68-75. doi: 10.1016/j.eururo.2012.02.020. Epub 2012 Feb 17.
PMID: 22366187RESULTPasoglou V, Michoux N, Peeters F, Larbi A, Tombal B, Selleslagh T, Omoumi P, Vande Berg BC, Lecouvet FE. Whole-body 3D T1-weighted MR imaging in patients with prostate cancer: feasibility and evaluation in screening for metastatic disease. Radiology. 2015 Apr;275(1):155-66. doi: 10.1148/radiol.14141242. Epub 2014 Dec 15.
PMID: 25513855RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
January 17, 2017
First Posted
January 27, 2017
Study Start
December 1, 2016
Primary Completion
December 18, 2017
Study Completion
March 1, 2019
Last Updated
May 10, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share