Trial Outcomes & Findings for Clinical Evaluation of Primary Sampling Scatter Correction for Chest Tomosynthesis (NCT NCT04076696)

Last Updated: 2022-08-08

Results Overview

Readers will rate their confidence in images from the experimental modality (sDCT with scatter correction) as compared to the conventional scan (chest CT with x-ray) on a 7 point Likert scale (-3 to 3) based on ability to identify lesion(s) present comparing each modality. A value of -3 is significantly less confident in the s-DCT representation 0 is the same confidence in modalities, and 3 is significantly more confident in the s-DCT representation compared to the conventional. Each individual will have a single value per reader. Two readers compared each scan. The overall reader preference between modalities was calculated by determining the mean value.

Recruitment status

COMPLETED

Study phase

Target enrollment

38 participants

Primary outcome timeframe

Baseline

Results posted on

2022-08-08

Participant Flow

Participant milestones

Participant milestones
Measure	Scatter Corrected s-DCT The study scan, s-DCT and correction scan, will be performed within two weeks of the patient's clinical evaluations by chest CT and x-ray. The study scan may be done within 2 weeks prior or two weeks following standard of care imaging. There cannot be any intervening therapies or procedures (i.e. biopsy or excision of lesions) done in between the standard of care (SOC) imaging and the s-DCT. All patients will have a breath held s-DCT scan in an anterior-posterior direction. Scatter corrected s-DCT: All patients will have a breath held s-DCT scan in an anterior-posterior direction
Overall Study STARTED	38
Overall Study COMPLETED	38
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Evaluation of Primary Sampling Scatter Correction for Chest Tomosynthesis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Scatter Corrected s-DCT n=38 Participants The study scan, s-DCT and correction scan, will be performed within two weeks of the patient's clinical evaluations by chest CT and x-ray. The study scan may be done within 2 weeks prior or two weeks following standard of care imaging. There cannot be any intervening therapies or procedures (i.e. biopsy or excision of lesions) done in between the standard of care (SOC) imaging and the s-DCT. All patients will have a breath held s-DCT scan in an anterior-posterior direction. Scatter corrected s-DCT: All patients will have a breath held s-DCT scan in an anterior-posterior direction
Age, Continuous	64 years STANDARD_DEVIATION 17 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	32 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	38 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	Scatter Corrected s-DCT n=38 Participants The study scan, s-DCT and correction scan, will be performed within two weeks of the patient's clinical evaluations by chest CT and x-ray. The study scan may be done within 2 weeks prior or two weeks following standard of care imaging. There cannot be any intervening therapies or procedures (i.e. biopsy or excision of lesions) done in between the standard of care (SOC) imaging and the s-DCT. All patients will have a breath held s-DCT scan in an anterior-posterior direction. Scatter corrected s-DCT: All patients will have a breath held s-DCT scan in an anterior-posterior direction
Reader Confidence in s-DCT Images Compared to Conventional CT (Units on a Scale)	-0.43 Units on a scale Standard Deviation 0.62

SECONDARY outcome

Timeframe: Baseline

Sensitivity will be defined as the ability of s-DCT images to detect lesions positively identified on gold standard CT images.

Outcome measures

Outcome measures
Measure	Scatter Corrected s-DCT n=38 Participants The study scan, s-DCT and correction scan, will be performed within two weeks of the patient's clinical evaluations by chest CT and x-ray. The study scan may be done within 2 weeks prior or two weeks following standard of care imaging. There cannot be any intervening therapies or procedures (i.e. biopsy or excision of lesions) done in between the standard of care (SOC) imaging and the s-DCT. All patients will have a breath held s-DCT scan in an anterior-posterior direction. Scatter corrected s-DCT: All patients will have a breath held s-DCT scan in an anterior-posterior direction
Sensitivity of s-DCT Images (Percentage of Positive Scans)	0.407 percentage of positive scans Interval 0.224 to 0.612

Adverse Events

Scatter Corrected s-DCT

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

Director, Clinical Research, Department of Radiology

University of North Carolina at Chapel Hill

Phone: 919-966-4997

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place