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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
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

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

45 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

    First Posted
    June 11, 2019
    Last Updated
    June 14, 2019
    Sponsor
    Universitaire Ziekenhuizen KU Leuven
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    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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