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

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

3 participants

Primary outcome timeframe

1 year

Results posted on

2021-02-18

Participant Flow

Participant milestones

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

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

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 year

Population: 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 events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Shirley Rodriguez

University of Chicago

Phone: 773-834-4337

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place