Whole-Body 3D T1-weighted MR Imaging An… | Clinical Trial

Key information

Conditions

Prostate Adenocarcinoma Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Metastasis Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–99 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

prostate cancer with high risk for metastases

Exclusion criteria

contraindications to MRI

Treatment and study plan

Diagnostic performance 3D T1

Diagnostic Test

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 outcomes

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, ...).

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Official study 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.

Acronym: TFE-TVE

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2019
First posted: Jan 27, 2017
Registry last updated: May 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed