Prostatic NeoplasmsGASNCT03987737
Rectal Gas Removal Through Small Catheter Placement Prior to MRI of the Prostate
A study testing small urinary catheter placement in the rectum in people with Prostatic Neoplasms and Prostate Cancer, run by Universitaire Ziekenhuizen KU Leuven.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 80 years, men only
- Conditions the study is for
- Prostatic Neoplasms, Prostate Cancer
- What is being tested?
- small urinary catheter placement in the rectum
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Aug 2019to Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Conditions
- Prostatic Neoplasms, Prostate Cancer
- Being tested
- small urinary catheter placement in the rectum
- Keywords
- Prostatic neoplasm, Prostate, bp MRI of the prostate, small rectal catheter placement
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
small urinary catheter placement in the rectumProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 week
Secondary outcomes (2)
Number of clinically significant cancers detected more due to improved quality of images
compared to control group, and with biopsy/pathological specimen as reference
Measured: within 1 year
Number of rescans due to insufficient image quality after small catheter placement
compared to control group
Measured: within 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study startAug 2019 (estimated)
- Primary completionOct 2019 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cindy Mai, MD, Principal investigator, University Hospital Leuven, Department of Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03987737
- Sponsor's protocol ID
- s.-nr
- Acronym
- GAS
- Status last verified
- Jun 2019
- First submitted
- 11 Jun 2019
- Last updated
- 17 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25656808Caglic 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.
PubMed 30611559Mazaheri 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.
PubMed 23830610Padhani 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.
PubMed 10348281Caglic 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.
PubMed 28583630Lim 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.
PubMed 25556957van 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.
PubMed 29362144McNair 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.
PubMed 25407867
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03987737
- Acronym / sponsor ID
- GAS / s.-nr
- Conditions
- Prostatic Neoplasms, Prostate Cancer
- Keywords
- Prostatic neoplasm, Prostate, bp MRI of the prostate, small rectal catheter placement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Aug 2019 (estimated)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 17 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| small catheter | Experimental | Procedure: small urinary catheter placement in the rectumIn 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. |
| control group | No intervention | –In the control arm, subjects will be scanned immediately after rectal evacuation on the toilet without small catheter in situ. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| small urinary catheter placement in the rectumThe 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. | Procedure or surgery | small catheter |
Primary outcome
degree of distortion of the prostate on AP direction on DWI compared to T2W images in mm
Time frame: 1 week
The difference in diameter in anterio-posterior direction between axial DWI and the corresponding T2W images
2 secondary outcomes
Number of clinically significant cancers detected more due to improved quality of images
Time frame: within 1 year
Number of rescans due to insufficient image quality after small catheter placement
Time frame: within 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2019.
- Results publication: PubMed 25656808Futterer 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 publication: PubMed 30611559Caglic 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 publication: PubMed 23830610Mazaheri 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 publication: PubMed 10348281Padhani 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 publication: PubMed 28583630Caglic 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 publication: PubMed 25556957Lim 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 publication: PubMed 29362144van 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 publication: PubMed 25407867McNair 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cindy Mai, MD principal investigator
University Hospital Leuven, Department of Radiology
Questions about this trial
What is this clinical trial studying?
A study testing small urinary catheter placement in the rectum in people with Prostatic Neoplasms and Prostate Cancer, run by Universitaire Ziekenhuizen KU Leuven.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cindy Mai, MD (003216345032, cindy.mai@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
degree of distortion of the prostate on AP direction on DWI compared to T2W images in mm (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03987737, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2019.