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

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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

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.

Condition or disease Intervention/treatment Phase
Prostate Adenocarcinoma Metastasis Diagnostic Test: Diagnostic performance 3D T1 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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.
Study Start Date : December 2016
Actual Primary Completion Date : December 18, 2017
Actual Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. 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, ...).




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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • prostate cancer with high risk for metastases

Exclusion Criteria:

  • contraindications to MRI

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03034070


Locations
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Belgium
Cliniques universitaires Saint-Luc
Brussels, Belgium, 1200
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Publications of Results:
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Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT03034070     History of Changes
Other Study ID Numbers: TFE TVE
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
MRI
MRI sequences
prostate cancer
cancer
staging
bone metastasis
node metastasis

Additional relevant MeSH terms:
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Prostatic Neoplasms
Adenocarcinoma
Neoplasm Metastasis
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplastic Processes
Pathologic Processes