Rectal Gas Removal Through Small Catheter Placement Prior to MRI of the Prostate (GAS)
Primary Purpose
Prostatic Neoplasms, Prostate Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
small urinary catheter placement in the rectum
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostatic Neoplasms focused on measuring Prostatic neoplasm, Prostate, bp MRI of the prostate, small rectal catheter placement
Eligibility Criteria
Inclusion Criteria:
- willing to participate in the study by giving written informed consent.
- male subjects aged between 45 to 80 years.
- scheduled for a prostate MRI due to clinical suspicion of prostatic carcinoma (elevated prostate specific antigen (PSA) levels in blood and/or abnormal digital rectal examination (DRE)), staging, follow-up or active surveillance.
- good health condition based on medical history, physical examination and vital sign measurements.
Exclusion Criteria:
- has a contra-indication for MRI (claustrophobia, non-compatible metallic implants).
- has a prior history of hip prosthesis.
- has any condition, physical, mental, familial or sociological, that could impede compliance with the study protocol and further follow-up. This is not an absolute contra-indication, but should be discussed with patient prior to registration in the trial.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
small catheter
control group
Arm Description
In the study arm, a small catheter will be placed in the rectum by the MRI technician and the examination will be executed with the small catheter in situ.
In the control arm, subjects will be scanned immediately after rectal evacuation on the toilet without small catheter in situ.
Outcomes
Primary Outcome Measures
degree of distortion of the prostate on AP direction on DWI compared to T2W images in mm
The difference in diameter in anterio-posterior direction between axial DWI and the corresponding T2W images
Secondary Outcome Measures
Number of clinically significant cancers detected more due to improved quality of images
compared to control group, and with biopsy/pathological specimen as reference
Number of rescans due to insufficient image quality after small catheter placement
compared to control group
Full Information
NCT ID
NCT03987737
First Posted
June 11, 2019
Last Updated
June 14, 2019
Sponsor
Universitaire Ziekenhuizen KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT03987737
Brief Title
Rectal Gas Removal Through Small Catheter Placement Prior to MRI of the Prostate
Acronym
GAS
Official Title
Rectal Gas Removal Through Small Catheter Placement Prior to MRI of the Prostate: Assessment of the Impact on Diffusion Weighted Images Artifacts and Diagnostic Accuracy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 2019 (Anticipated)
Primary Completion Date
October 2019 (Anticipated)
Study Completion Date
October 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The presence of rectal gas can cause distortion at air-tissue interfaces on diffusion-weighted images (DWI) of prostate MRI and reduce image quality due to these susceptibility artifacts. Small catheter placement in the rectum before MRI is one of the ways that is advocated in PI-RADS v2 guidelines to reduce rectal gas. The goal of this study is to prospectively evaluate the effect of small catheter placement on artifacts on diffusion weighted images and to see whether it improves diagnostic accuracy.
Detailed Description
The value of MRI in the detection of clinically significant prostate cancer has already been shown in many studies [1]. With MRI widely available and general accepted by urologists and radiologist for prostate imaging, a good execution and high quality of the images have become crucial. Recently Caglic et al published an article about optimizing prostate mpMRI [2]. One of the factors that influences image quality is rectal loading and bowel movement. The prostate is located anterior in the immediate vicinity of the rectum, so prostatic MRI is prone to artifacts caused by bowel movements and to susceptibility artifacts at the air-tissue interface [3]. Rectal movements are correlated to the degree of rectal distension and result in significant displacement of the prostate gland [4]. Rectal distension has a negative impact on the quality of both T2-weighted (T2W) and diffusion weighted images (DWI) [5], which are the two most important sequences in the detection of clinically significant prostate cancer. A study by Lim et al [6] showed a significant correlation between the amount of stool in the rectum and the severity of motion artifacts, however reducing the amount of stool with an enema did not improve the quality of T2W, DWI or dynamic contrast enhanced (DCE) images compared to the non-enema group. As the authors have declared, this could be due to the fact that only a minority of patients in the non-enema group had moderate or large amounts of stool (15.6%).
This study by Lim et al also showed that the amount of rectal gas did not correlate with the severity of distortion artifacts on diffusion images, which could mean that even a small amount of gas could already cause substantial (susceptibility) artifacts on DWI. A larger study by Griethuysen et al [7] showed that a micro-enema shortly before the examination reduces both the incidence and the severity of gas-induced artifacts.
So, moving gas appears to be the main concern and preparation is recommended. There is no evidence that one rectal emptying strategy is better than another [8]. In PI-RADS v2, different approaches are suggested, the aforementioned micro-enema, performing the MRI exam with patient in the prone position or to decompress the rectum using a small catheter [9].
This study aims to assess the efficacy of small catheter placement just before the MRI examination in reducing susceptibility on diffusion weighted images.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms, Prostate Cancer
Keywords
Prostatic neoplasm, Prostate, bp MRI of the prostate, small rectal catheter placement
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a prospective, single center, comparative study between two rectal emptying strategies. Patients will be randomized into one of two arms. In both arms the subjects will be asked to evacuate the rectum as much as possible prior to the MRI exam. In the study arm, a small catheter will be placed in the rectum by the MRI technician and the examination will be executed with the small catheter in situ. In the control arm, subjects will be scanned immediately after rectal evacuation on the toilet. If the DWI sequence is non-interpretable due to susceptibility artefacts, excessive air will be removed with small catheter placement eventually and the scan will be repeated.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
small catheter
Arm Type
Experimental
Arm Description
In the study arm, a small catheter will be placed in the rectum by the MRI technician and the examination will be executed with the small catheter in situ.
Arm Title
control group
Arm Type
No Intervention
Arm Description
In the control arm, subjects will be scanned immediately after rectal evacuation on the toilet without small catheter in situ.
Intervention Type
Procedure
Intervention Name(s)
small urinary catheter placement in the rectum
Intervention Description
The MRI technician will place a small urinary catheter in the rectum prior to MRI of the prostate to evacuate excessive gasses. This catheter will stay in the rectum during the whole MRI examination.
Primary Outcome Measure Information:
Title
degree of distortion of the prostate on AP direction on DWI compared to T2W images in mm
Description
The difference in diameter in anterio-posterior direction between axial DWI and the corresponding T2W images
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Number of clinically significant cancers detected more due to improved quality of images
Description
compared to control group, and with biopsy/pathological specimen as reference
Time Frame
within 1 year
Title
Number of rescans due to insufficient image quality after small catheter placement
Description
compared to control group
Time Frame
within 1 year
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
participants needs to have a prostate
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
willing to participate in the study by giving written informed consent.
male subjects aged between 45 to 80 years.
scheduled for a prostate MRI due to clinical suspicion of prostatic carcinoma (elevated prostate specific antigen (PSA) levels in blood and/or abnormal digital rectal examination (DRE)), staging, follow-up or active surveillance.
good health condition based on medical history, physical examination and vital sign measurements.
Exclusion Criteria:
has a contra-indication for MRI (claustrophobia, non-compatible metallic implants).
has a prior history of hip prosthesis.
has any condition, physical, mental, familial or sociological, that could impede compliance with the study protocol and further follow-up. This is not an absolute contra-indication, but should be discussed with patient prior to registration in the trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cindy Mai, MD
Phone
003216345032
Email
cindy.mai@uzleuven.be
First Name & Middle Initial & Last Name or Official Title & Degree
Hilde Vandenhout
Phone
003216343636
Email
hilde.vandenhout@uzleuven.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cindy Mai, MD
Organizational Affiliation
University Hospital Leuven, Department of Radiology
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25656808
Citation
Futterer JJ, Briganti A, De Visschere P, Emberton M, Giannarini G, Kirkham A, Taneja SS, Thoeny H, Villeirs G, Villers A. Can Clinically Significant Prostate Cancer Be Detected with Multiparametric Magnetic Resonance Imaging? A Systematic Review of the Literature. Eur Urol. 2015 Dec;68(6):1045-53. doi: 10.1016/j.eururo.2015.01.013. Epub 2015 Feb 2.
Results Reference
result
PubMed Identifier
30611559
Citation
Caglic I, Barrett T. Optimising prostate mpMRI: prepare for success. Clin Radiol. 2019 Nov;74(11):831-840. doi: 10.1016/j.crad.2018.12.003. Epub 2019 Jan 2.
Results Reference
result
PubMed Identifier
23830610
Citation
Mazaheri Y, Vargas HA, Nyman G, Akin O, Hricak H. Image artifacts on prostate diffusion-weighted magnetic resonance imaging: trade-offs at 1.5 Tesla and 3.0 Tesla. Acad Radiol. 2013 Aug;20(8):1041-7. doi: 10.1016/j.acra.2013.04.005.
Results Reference
result
PubMed Identifier
10348281
Citation
Padhani AR, Khoo VS, Suckling J, Husband JE, Leach MO, Dearnaley DP. Evaluating the effect of rectal distension and rectal movement on prostate gland position using cine MRI. Int J Radiat Oncol Biol Phys. 1999 Jun 1;44(3):525-33. doi: 10.1016/s0360-3016(99)00040-1.
Results Reference
result
PubMed Identifier
28583630
Citation
Caglic I, Hansen NL, Slough RA, Patterson AJ, Barrett T. Evaluating the effect of rectal distension on prostate multiparametric MRI image quality. Eur J Radiol. 2017 May;90:174-180. doi: 10.1016/j.ejrad.2017.02.029. Epub 2017 Feb 22.
Results Reference
result
PubMed Identifier
25556957
Citation
Lim C, Quon J, McInnes M, Shabana WM, El-Khodary M, Schieda N. Does a cleansing enema improve image quality of 3T surface coil multiparametric prostate MRI? J Magn Reson Imaging. 2015 Sep;42(3):689-97. doi: 10.1002/jmri.24833. Epub 2014 Dec 30.
Results Reference
result
PubMed Identifier
29362144
Citation
van Griethuysen JJM, Bus EM, Hauptmann M, Lahaye MJ, Maas M, Ter Beek LC, Beets GL, Bakers FCH, Beets-Tan RGH, Lambregts DMJ. Gas-induced susceptibility artefacts on diffusion-weighted MRI of the rectum at 1.5 T - Effect of applying a micro-enema to improve image quality. Eur J Radiol. 2018 Feb;99:131-137. doi: 10.1016/j.ejrad.2017.12.020. Epub 2017 Dec 28.
Results Reference
result
PubMed Identifier
25407867
Citation
McNair HA, Wedlake L, Lips IM, Andreyev J, Van Vulpen M, Dearnaley D. A systematic review: effectiveness of rectal emptying preparation in prostate cancer patients. Pract Radiat Oncol. 2014 Nov-Dec;4(6):437-47. doi: 10.1016/j.prro.2014.06.005. Epub 2014 Aug 3.
Results Reference
result
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Rectal Gas Removal Through Small Catheter Placement Prior to MRI of the Prostate
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