Trial Outcomes & Findings for Evaluation of TaiHao Breast Ultrasound Diagnosis Software (NCT NCT04551105)
NCT ID: NCT04551105
Last Updated: 2022-11-02
Results Overview
The area under the LROC curve (AUC\_LROC) on the diagnosis of benign and malignant lesions was computed and compared for Aim 1 (baseline) and Arm 2 (with BU-CAD assistance) studies.
COMPLETED
NA
16 participants
10 weeks
2022-11-02
Participant Flow
Six hundred and twenty-eight cases were randomized and split into two groups (A and B) with the same number of cases (314) in each group. Sixteen readers were randomized and split into two groups (X and Y) with the same number of readers (8) in each group.
628 cases were randomly split into study datasets A and B. Each dataset had 314 cases. For each session, sub-datasets A and B were randomized within the group. Then, a reader read each sub-dataset either unaided or aided by the BU-CAD system.
Unit of analysis: cases
Participant milestones
| Measure |
Arm 1
Group X readers read group A cases first unaided and then group B cases aided. At least 5 weeks later, group X readers read group B cases unaided, then group A cases aided.
|
Arm2
Group Y readers read group B cases first unaided and then group A cases aided. At least 5 weeks later, group Y readers read group A cases unaided, then group B cases aided.
|
|---|---|---|
|
The 1st Study Sessions
STARTED
|
8 314
|
8 314
|
|
The 1st Study Sessions
COMPLETED
|
8 314
|
8 314
|
|
The 1st Study Sessions
NOT COMPLETED
|
0 0
|
0 0
|
|
The 2st Study Sessions (5 Weeks Later)
STARTED
|
8 314
|
8 314
|
|
The 2st Study Sessions (5 Weeks Later)
COMPLETED
|
8 314
|
8 314
|
|
The 2st Study Sessions (5 Weeks Later)
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Without BU-CAD Decision Support Assistance
n=8 Participants
Group X readers read group A cases(314) first unaided and then group B cases(314) aided. At least 5 weeks later, group X readers read group B cases(314) unaided, then group A cases(314) aided.
|
With BU-CAD Decision Support Assistance
n=8 Participants
Group Y readers read group B cases(314) first unaided and then group A cases(314) aided. At least 5 weeks later, group Y readers read group A cases(314) unaided, then group B(314) cases aided.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=16 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
16 Participants
n=16 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=16 Participants
|
|
Sex/Gender, Customized
Female
|
6 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
11 Participants
n=16 Participants
|
|
Sex/Gender, Customized
Male
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
5 Participants
n=16 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
8 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
16 Participants
n=16 Participants
|
PRIMARY outcome
Timeframe: 10 weeksPopulation: Of the study breast ultrasound cases, some contained malignant lesions and some contained breast contained benign lesions.
The area under the LROC curve (AUC\_LROC) on the diagnosis of benign and malignant lesions was computed and compared for Aim 1 (baseline) and Arm 2 (with BU-CAD assistance) studies.
Outcome measures
| Measure |
Arm 1
n=628 case
read each breast ultrasound case without the BU-CAD decision support assistance referred to as the unaided (or baseline) study
|
Arm 2
n=628 case
read each breast ultrasound case with the aid of BU-CAD decision support referred to as 'aided study
|
|---|---|---|
|
Comparing the Area Under the LROC Curve
|
0.7786 probability
Interval 0.7463 to 0.8109
|
0.8160 probability
Interval 0.7862 to 0.8458
|
SECONDARY outcome
Timeframe: 10 weeksPopulation: Of the study breast ultrasound cases, some contained malignant lesions and some contained breast contained benign lesions.
Each reader's reading time of a case was automatically recorded by the BU-CAD system. the average reading times of 16 readers with and without outlier reading times were compared between the aided and unaided sessions using the paired t-test.
Outcome measures
| Measure |
Arm 1
n=628 case
read each breast ultrasound case without the BU-CAD decision support assistance referred to as the unaided (or baseline) study
|
Arm 2
n=628 case
read each breast ultrasound case with the aid of BU-CAD decision support referred to as 'aided study
|
|---|---|---|
|
The Reading Time Was Computed and Compared for Aim 1 (Baseline) and Arm 2 (With BU-CAD Assistance) Studies.
|
31.75 second
Interval 11.24 to 52.25
|
18.96 second
Interval 3.25 to 34.67
|
SECONDARY outcome
Timeframe: 10 weeksPopulation: Of the study breast ultrasound cases, some contained malignant lesions and some contained breast contained benign lesions.
The mean sensitivity, specificity, PPV, and NPV of 16 readers were calculated and compared between the aided and unaided sessions using McNemar's test.
Outcome measures
| Measure |
Arm 1
n=628 case
read each breast ultrasound case without the BU-CAD decision support assistance referred to as the unaided (or baseline) study
|
Arm 2
n=628 case
read each breast ultrasound case with the aid of BU-CAD decision support referred to as 'aided study
|
|---|---|---|
|
The Sensitivity, Specificity, PPV, and NPV Were Computed and Compared for Aim 1 (Baseline) and Arm 2 (With BU-CAD Assistance) Studies.
Sensitivity
|
0.9225 proportion
Interval 0.8896 to 0.9554
|
0.9353 proportion
Interval 0.905 to 0.9655
|
|
The Sensitivity, Specificity, PPV, and NPV Were Computed and Compared for Aim 1 (Baseline) and Arm 2 (With BU-CAD Assistance) Studies.
Specificity
|
0.3165 proportion
Interval 0.2694 to 0.3636
|
0.3611 proportion
Interval 0.3124 to 0.4098
|
|
The Sensitivity, Specificity, PPV, and NPV Were Computed and Compared for Aim 1 (Baseline) and Arm 2 (With BU-CAD Assistance) Studies.
PPV
|
0.4876 proportion
Interval 0.4433 to 0.5319
|
0.5056 proportion
Interval 0.4607 to 0.5505
|
|
The Sensitivity, Specificity, PPV, and NPV Were Computed and Compared for Aim 1 (Baseline) and Arm 2 (With BU-CAD Assistance) Studies.
NPV
|
0.8623 proportion
Interval 0.8048 to 0.9198
|
0.8945 proportion
Interval 0.8456 to 0.9434
|
Adverse Events
First Session: Manual Review First and Then Review With CADx
First Session: Review With CADx First and Then Manual Review
Second Session: Manual Review First and Then Review With CADx
Second Session: Review With CADx First and Then Manual Review
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