Trial Outcomes & Findings for Utility of Diffusion-weighted MR Imaging (NCT NCT03078868)
NCT ID: NCT03078868
Last Updated: 2021-02-18
Results Overview
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
TERMINATED
NA
3 participants
1 year
2021-02-18
Participant Flow
Participant milestones
| Measure |
Single-point Intervention
magnetic resonance scanner
Magnetic Resonance Scanner: MRI
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Single-point Intervention
magnetic resonance scanner
Magnetic Resonance Scanner: MRI
|
|---|---|
|
Overall Study
Physician Decision
|
3
|
Baseline Characteristics
Gender information/data not collected
Baseline characteristics by cohort
| Measure |
Single-point Intervention
n=3 Participants
magnetic resonance scanner
Magnetic Resonance Scanner: MRI
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=3 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=3 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=3 Participants
|
|
Sex/Gender, Customized
Total Participants
|
0 Participants
Gender information/data not collected
|
|
Region of Enrollment
United States
|
3 participants
n=3 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: study terminated for lack of accrual and PI left institution
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
Outcome measures
Outcome data not reported
Adverse Events
Single-point Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place