Rectal Gas Removal Through Small Catheter Placement Prior to MRI of the Prostate

NCT03987737 | Unknown

• 1 other identifier: s.-nr
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Prostatic Neoplasms; Prostate Cancer

Keywords

Prostatic neoplasm; Prostate; bp MRI of the prostate; small rectal catheter placement

Outcome Measures

Primary Outcomes (1)

• 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

  1 week

Secondary Outcomes (2)

• Number of clinically significant cancers detected more due to improved quality of images

  within 1 year

• Number of rescans due to insufficient image quality after small catheter placement

  within 1 year

Study Arms (2)

small catheter

EXPERIMENTAL

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.

Procedure: small urinary catheter placement in the rectum

control group

NO INTERVENTION

In the control arm, subjects will be scanned immediately after rectal evacuation on the toilet without small catheter in situ.

Interventions

small urinary catheter placement in the rectum PROCEDURE

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.

small catheter

Eligibility Criteria

• Age: 45 Years - 80 Years
• Gender Eligibility Details: participants needs to have a prostate
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Related Publications (8)

• 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.

  PMID: 25656808 RESULT

• 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.

  PMID: 30611559 RESULT

• 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.

  PMID: 23830610 RESULT

• 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.

  PMID: 10348281 RESULT

• 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.

  PMID: 28583630 RESULT

• 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.

  PMID: 25556957 RESULT

• 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.

  PMID: 29362144 RESULT

• 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.

  PMID: 25407867 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Cindy Mai, MD

  University Hospital Leuven, Department of Radiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cindy Mai, MD

CONTACT

003216345032; cindy.mai@uzleuven.be

Hilde Vandenhout

CONTACT

003216343636; hilde.vandenhout@uzleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: June 17, 2019
• Study Start: August 1, 2019
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2020
• Last Updated: June 17, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share