DWMDWMRINCT03078868
Utility of Diffusion-weighted MR Imaging
A study testing Magnetic Resonance Scanner in people with DWM, run by University of Chicago at 1 site in United States.
Trial summary
To determine whether DW-MRI is applicable in the evaluation of post-operative collections, and whether utilization of DW-MRI can enhance application of percutaneous drainage and prevent unnecessary drainage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- DWM
- What is being tested?
- Magnetic Resonance Scanner
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2017to 18 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients who have undergone a colon or rectal resection at UCM and have developed a CT-proven abdominopelvic fluid collection > 3 cm in greatest dimension
Who cannot join
- Adult patients who have not undergone a colon or rectal resection at UCM and have developed a CT-proven abdominopelvic fluid collection > 3 cm in greatest dimension.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Utility of Diffusion-weighted MR Imaging in Guiding Selective Percutaneous Drainage of Postoperative Intra-abdominal Abscesses After Colorectal Resection
To determine whether DW-MRI is applicable in the evaluation of post-operative collections, and whether utilization of DW-MRI can enhance application of percutaneous drainage and prevent unnecessary drainage.
Read the detailed description
Percutaneous drainage of intra-abdominal abscesses occurring as a complication of colon and rectal resection has been a major advance in the management of surgical patients. Proper patient selection is critical for safe and effective management in this population. Almost ¾ of patients undergoing CT scan after colorectal resection due to clinical suspicion of intrabdominal process will have at least one fluid collection identified. These collections can represent a spectrum of clinical entities and there is not a consensus on the most effective management of these collections or even the definition of abscess. Currently, reliance on radiologic criteria in isolation can lead to overuse of interventional procedures. For example, 40% of rim-enhancing collections are sterile on aspiration. The surgeons' clinical suspicion for abscess and radiologic proximity to an anastomosis are the only criteria that are useful in predicting abscess versus sterile collection. A further consideration is the natural history of these abscesses. Studies in the diverticulitis literature have demonstrated that abscesses less than 3 cm in greatest dimension are successfully managed with antibiotics alone, while abscesses greater than 6.5 cm are likely to require intervention. However, this leaves a great number of abscesses between 3 cm and 6.5 cm that fall into uncertain grounds. In contrast to diverticulitis, where it can be reasonably inferred that an associated abdominopelvic collection is indeed and abscess, management of fluid collections identified post-operatively and determination of who will benefit from drainage is less clear. A novel radiologic technique with high discrimination between sterile and infected collection would be of great clinical utility in the post-operative management of fluid collections after colorectal resection.
The proposed research project seeks to broaden applicability of a proven but rarely used method, diffusion weighted magnetic resonance imaging (DW-MRI), to discriminate sterile or benign from infected abdominopelvic fluid collections, in order to enhance the utilization of percutaneous drainage in the post-operative setting after colorectal resection. Ability to streamline a limited MRI protocol to efficiently obtain diffusion weighted imaging of the abdominal cavity will be key to applying this methodology into daily practice. Secondly, it is not known whether DW-MRI can effectively discriminate specifically post-operative sterile collections from abscesses. This is one of the primary aims of this pilot study and will be used to generate hypothesis for a full-scale study.
Adult patients who have undergone a colon or rectal resection at the University of Chicago Medicine and have developed a CT-proven abdominopelvic fluid collection > 3 cm in greatest dimension will be eligible for inclusion in the study. The surgeon will then determine using traditional clinical and radiologic factors whether percutaneous drainage is desired. All patients with discrete abdominopelvic fluid collections > 3 cm in greatest dimension will undergo DW-MRI, and then be taken directly to the interventional radiology suite for drainage, or continue best medical care if drainage is felt to be unnecessary. Fluid will be sent for culture and gram stain, as well as cell count. In addition, the interventional radiology team will qualify the fluid in their notation as 'purulent', 'serous', 'sanguinous', etc.. Any patients initially managed without drainage who fail this medical management and ultimately undergo percutaneous drainage will be considered the crossover group.
DW-MRI readings will be analyzed and ADC values will be compared and validated in an attempt to report a threshold apparent diffusion coefficient (ADC) that reliably discriminates sterile and infected post-operative fluid collections. The effect size from utilization of DW-MRI (defined as a change in management decision to pursue drainage or hold on drainage) to determine if this is a useful clinical tool. Because it is not yet know how DW-MRI should be interpreted in this clinical setting, the DW-MRI acquisition will not be utilized in any way in the clinical care of the study patients. The DW-MRI data is considered a single-point intervention and will only be used to define an ADC threshold that can discriminate sterile from infected collections. The data will help us to identify potential limitations of DWI in differentiation of abscess from non-infected collections and allow us to determine the appropriate cohort size for a future clinical trial. Based on the correlation with DWI and clinical data, we will explore and suggest novel acquisition and analysis methods for quantitative DWI.
- Conditions
- DWM
- Being tested
- Magnetic Resonance Scanner
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ScannerDevice
MRI
| Study group | Role | What they receive |
|---|---|---|
| Single-point intervention | Experimental | magnetic resonance scanner Receives: Device: Magnetic Resonance Scanner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apparent Diffusion Coefficient (ADC) From Infected Post-operative Fluid Collections
Two radiologists will independently review the MR images for detection of collections. ADC maps will be generated for each patient. Each radiologist will assign a 1-5 point score based on the level of confidence in the diagnosis of abscess. These radiologists will then measure ADC of the collections in each patient on ADC maps. Mean and 10th percentile ADC values will be computed by placement of region of interest (ROI) on ADC maps using DW images as guide. Each ROI will be placed in the center of the collection over the darkest pixels on ADC maps keeping size as large as possible and avoiding the volume averaging from the surrounding tissue. The reference standard for the diagnosis of abscess will be based on the analysis of aspiration fluid from the collection. Following statistical analysis, an ROC curve will be constructed for ADC values, and area under the curve measured forthe overall ability of ADC in differentiation of abscess from non-infected collections
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2017
- Study start15 Feb 2017
- Primary completion18 Jun 2019
- Study completion18 Jun 2019
Why it stopped: lack of accrual and PI left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DWMStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa Cannon, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03078868
- Sponsor's protocol ID
- IRB16-1771
- Acronym
- DWMRI
- Status last verified
- Feb 2021
- First submitted
- 23 Feb 2017
- Last updated
- 18 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: N/A-data won't be shared
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Diffusion-weighted MR Imaging in Guiding Selective Percutaneous Drainage of Postoperative Intra-abdominal Abscesses After Colorectal Resection
- ClinicalTrials.gov ID
- NCT03078868
- Acronym / sponsor ID
- DWMRI / IRB16-1771
- Conditions
- DWM
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of accrual and PI left institution
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 18 Jun 2019 (actual)
- Study completion
- 18 Jun 2019 (actual)
- First posted
- 14 Mar 2017 (actual)
- Results
- Posted 18 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine whether DW-MRI is applicable in the evaluation of post-operative collections, and whether utilization of DW-MRI can enhance application of percutaneous drainage and prevent unnecessary drainage.
Detailed description
Percutaneous drainage of intra-abdominal abscesses occurring as a complication of colon and rectal resection has been a major advance in the management of surgical patients. Proper patient selection is critical for safe and effective management in this population. Almost ¾ of patients undergoing CT scan after colorectal resection due to clinical suspicion of intrabdominal process will have at least one fluid collection identified. These collections can represent a spectrum of clinical entities and there is not a consensus on the most effective management of these collections or even the definition of abscess. Currently, reliance on radiologic criteria in isolation can lead to overuse of interventional procedures. For example, 40% of rim-enhancing collections are sterile on aspiration. The surgeons' clinical suspicion for abscess and radiologic proximity to an anastomosis are the only criteria that are useful in predicting abscess versus sterile collection. A further consideration is the natural history of these abscesses. Studies in the diverticulitis literature have demonstrated that abscesses less than 3 cm in greatest dimension are successfully managed with antibiotics alone, while abscesses greater than 6.5 cm are likely to require intervention. However, this leaves a great number of abscesses between 3 cm and 6.5 cm that fall into uncertain grounds. In contrast to diverticulitis, where it can be reasonably inferred that an associated abdominopelvic collection is indeed and abscess, management of fluid collections identified post-operatively and determination of who will benefit from drainage is less clear. A novel radiologic technique with high discrimination between sterile and infected collection would be of great clinical utility in the post-operative management of fluid collections after colorectal resection.
The proposed research project seeks to broaden applicability of a proven but rarely used method, diffusion weighted magnetic resonance imaging (DW-MRI), to discriminate sterile or benign from infected abdominopelvic fluid collections, in order to enhance the utilization of percutaneous drainage in the post-operative setting after colorectal resection. Ability to streamline a limited MRI protocol to efficiently obtain diffusion weighted imaging of the abdominal cavity will be key to applying this methodology into daily practice. Secondly, it is not known whether DW-MRI can effectively discriminate specifically post-operative sterile collections from abscesses. This is one of the primary aims of this pilot study and will be used to generate hypothesis for a full-scale study.
Adult patients who have undergone a colon or rectal resection at the University of Chicago Medicine and have developed a CT-proven abdominopelvic fluid collection > 3 cm in greatest dimension will be eligible for inclusion in the study. The surgeon will then determine using traditional clinical and radiologic factors whether percutaneous drainage is desired. All patients with discrete abdominopelvic fluid collections > 3 cm in greatest dimension will undergo DW-MRI, and then be taken directly to the interventional radiology suite for drainage, or continue best medical care if drainage is felt to be unnecessary. Fluid will be sent for culture and gram stain, as well as cell count. In addition, the interventional radiology team will qualify the fluid in their notation as 'purulent', 'serous', 'sanguinous', etc.. Any patients initially managed without drainage who fail this medical management and ultimately undergo percutaneous drainage will be considered the crossover group.
DW-MRI readings will be analyzed and ADC values will be compared and validated in an attempt to report a threshold apparent diffusion coefficient (ADC) that reliably discriminates sterile and infected post-operative fluid collections. The effect size from utilization of DW-MRI (defined as a change in management decision to pursue drainage or hold on drainage) to determine if this is a useful clinical tool. Because it is not yet know how DW-MRI should be interpreted in this clinical setting, the DW-MRI acquisition will not be utilized in any way in the clinical care of the study patients. The DW-MRI data is considered a single-point intervention and will only be used to define an ADC threshold that can discriminate sterile from infected collections. The data will help us to identify potential limitations of DWI in differentiation of abscess from non-infected collections and allow us to determine the appropriate cohort size for a future clinical trial. Based on the correlation with DWI and clinical data, we will explore and suggest novel acquisition and analysis methods for quantitative DWI.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-point intervention | Experimental | Device: Magnetic Resonance Scannermagnetic resonance scanner |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients who have undergone a colon or rectal resection at UCM and have developed a CT-proven abdominopelvic fluid collection > 3 cm in greatest dimension
Key exclusion criteria (1 listed)
- Adult patients who have not undergone a colon or rectal resection at UCM and have developed a CT-proven abdominopelvic fluid collection > 3 cm in greatest dimension.
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 |
|---|---|---|
| Magnetic Resonance ScannerMRI | Device | Single-point intervention |
Primary outcome
Apparent Diffusion Coefficient (ADC) From Infected Post-operative Fluid Collections
Time frame: 1 year
Two radiologists will independently review the MR images for detection of collections. ADC maps will be generated for each patient. Each radiologist will assign a 1-5 point score based on the level of confidence in the diagnosis of abscess. These radiologists will then measure ADC of the collections in each patient on ADC maps. Mean and 10th percentile ADC values will be computed by placement of region of interest (ROI) on ADC maps using DW images as guide. Each ROI will be placed in the center of the collection over the darkest pixels on ADC maps keeping size as large as possible and avoiding the volume averaging from the surrounding tissue. The reference standard for the diagnosis of abscess will be based on the analysis of aspiration fluid from the collection. Following statistical analysis, an ROC curve will be constructed for ADC values, and area under the curve measured forthe overall ability of ADC in differentiation of abscess from non-infected collections
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. N/A-data won't be shared
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.
Lisa Cannon, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Scanner in people with DWM, run by University of Chicago at 1 site in United States.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 18 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apparent Diffusion Coefficient (ADC) From Infected Post-operative Fluid Collections (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Feb 2021; AzTrials last refreshed its copy on 28 Oct 2026.