Breast CancerNCT04551105

Evaluation of TaiHao Breast Ultrasound Diagnosis Software

A study testing Reader Group X - Session 1, Reader Group Y - Session 1 and Reader Group X - Session 2 in people with Breast Cancer and Breast Diseases, run by TaiHao Medical Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The BR-USCAD DS Module is a computer-assisted detection and diagnosis software based on a deep learning algorithm. This retrospective, fully-crossed, multi-reader, multi-case (MRMC) study aims to compare the performances of readers without and with the aid of the Breast Ultrasound Image Reviewed with Assistance of… Read more about this study

Who is it for?: Ages 21 years and older, women only
Conditions the study is for: Breast Cancer, Breast Diseases
What is being tested?: Reader Group X - Session 1, Reader Group Y - Session 1 and Reader Group X - Session 2
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteUnited States
Study dates: 15 Aug 2020to 1 Nov 2020
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 21 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

B-mode breast ultrasound image
Female, age 21 or older
Breast lesion images acquired before a biopsy or surgery - these images were retrospectively collected with histology report.
Non-biopsied benign lesions with negative follow-up for a minimum of 24 months
At least two orthogonal views of a lesion

Who cannot join

Breast lesion images acquired after biopsy or surgery.
Any breast surgeries or interventional procedures in the 12 months prior to ultrasound imaging
Case demonstrating administrative or technical errors
Multiple lesions in one 2-D ultrasound image
Breast ultrasound images with Doppler, elastography, or other overlays present
Case with less than 2-year follow-up and without biopsy confirmation

Trial locations and contacts

1 site in 1 country.

United States1 site

Arlington Innovation Center: Health Research - Virginia Tech
Arlington, Virginia, 22203

Other trials in United States

About this study

Conditions: Breast Cancer, Breast Diseases
Being tested: Reader Group X - Session 1, Reader Group Y - Session 1, Reader Group X - Session 2, Reader Group Y - Session 2
Medical subject headings: Breast Neoplasms, Breast Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Reader Group X - Session 1Diagnostic test
Each rater in "Reader Group X" will interpret the "dataset A" cases in different random order without BR-USCAD DS and interpret the "dataset B" cases in different random order with BR-USCAD DS.
Reader Group Y - Session 1Diagnostic test
Each rater in "Reader Group Y" will interpret the "dataset A" cases in different random order with BR-USCAD DS and interpret the "dataset B" cases in different random order without BR-USCAD DS.
Reader Group X - Session 2Diagnostic test
Each rater in "Reader Group X" will interpret the "dataset A" cases in different random order with BR-USCAD DS and interpret the "dataset B" cases in different random order without BR-USCAD DS.
Reader Group Y - Session 2Diagnostic test
Each rater in "Reader Group Y" will interpret the "dataset A" cases in different random order without BR-USCAD DS and interpret the "dataset B" cases in different random order with BR-USCAD DS.

Study groups in NCT04551105
Study group	Role	What they receive
First session: manual review first and then review with CADx	Active comparator	Reader Group X interpret the "Dataset A" cases in different random order without any assistance of AI first, and then interpret the "Dataset B" cases in different random order with TaiHao AI system. Receives: Diagnostic Test: Reader Group X - Session 1
First session: review with CADx first and then manual review	Active comparator	Reader Group Y interpret the "Dataset A" cases in different random order with TaiHao AI system first, and then interpret the "Dataset B" cases in different random order without any assistance of AI. Receives: Diagnostic Test: Reader Group Y - Session 1
Second session: manual review first and then review with CADx	Active comparator	At least 4 weeks after first session for memory washing out. Reader Group X interpret the "Dataset A" cases in different random order with TaiHao AI system first, and then interpret the "Dataset B" cases in different random order without any assistance of AI. Receives: Diagnostic Test: Reader Group X - Session 2
Second session: review with CADx first and then manual review	Active comparator	At least 4 weeks after first session for memory washing out. Rader Group Y interpret the "Dataset A" cases in different random order without any assistance of AI first, and then interpret the "Dataset B" cases in different random order with TaiHao AI system. Receives: Diagnostic Test: Reader Group Y - Session 2

What is being measured

The primary outcome is the main question the study is designed to answer.

Comparing the Area Under the LROC Curve
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.
Measured: 10 weeks

Secondary outcomes (2)

The Reading Time Was Computed and Compared for Aim 1 (Baseline) and Arm 2 (With BU-CAD Assistance) Studies.
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.
Measured: 10 weeks
The Sensitivity, Specificity, PPV, and NPV Were Computed and Compared for Aim 1 (Baseline) and Arm 2 (With BU-CAD Assistance) Studies.
The mean sensitivity, specificity, PPV, and NPV of 16 readers were calculated and compared between the aided and unaided sessions using McNemar's test.
Measured: 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Aug 20201 Nov 2020

First posted16 Sep 2020
Study start15 Aug 2020
Primary completion1 Nov 2020
Study completion1 Nov 2020

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 Breast CancerStudies of the same condition, open and under way.
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: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04551105
Sponsor's protocol ID: TaiHao BR-USCAD VT 20-249
Status last verified: Oct 2022
First submitted: 2 Sep 2020
Last updated: 2 Nov 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of TaiHao Breast Ultrasound Diagnosis Software
ClinicalTrials.gov ID: NCT04551105
Acronym / sponsor ID: TaiHao BR-USCAD VT 20-249
Conditions: Breast Cancer, Breast Diseases
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: TaiHao Medical Inc.Industry (pharma, biotech, devices)
Collaborators: Columbia University, Taipei Veterans General Hospital, Taiwan, Virginia Polytechnic Institute and State University
Study start: 15 Aug 2020 (actual)
Primary completion: 1 Nov 2020 (actual)
Study completion: 1 Nov 2020 (actual)
First posted: 16 Sep 2020 (actual)
Results: Posted 2 Nov 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
First session: manual review first and then review with CADx	Active comparator	Diagnostic Test: Reader Group X - Session 1Reader Group X interpret the "Dataset A" cases in different random order without any assistance of AI first, and then interpret the "Dataset B" cases in different random order with TaiHao AI system.
First session: review with CADx first and then manual review	Active comparator	Diagnostic Test: Reader Group Y - Session 1Reader Group Y interpret the "Dataset A" cases in different random order with TaiHao AI system first, and then interpret the "Dataset B" cases in different random order without any assistance of AI.
Second session: manual review first and then review with CADx	Active comparator	Diagnostic Test: Reader Group X - Session 2At least 4 weeks after first session for memory washing out. Reader Group X interpret the "Dataset A" cases in different random order with TaiHao AI system first, and then interpret the "Dataset B" cases in different random order without any assistance of AI.
Second session: review with CADx first and then manual review	Active comparator	Diagnostic Test: Reader Group Y - Session 2At least 4 weeks after first session for memory washing out. Rader Group Y interpret the "Dataset A" cases in different random order without any assistance of AI first, and then interpret the "Dataset B" cases in different random order with TaiHao AI system.

Who may qualify

Ages: 21 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

B-mode breast ultrasound image
Female, age 21 or older
Breast lesion images acquired before a biopsy or surgery - these images were retrospectively collected with histology report.
Non-biopsied benign lesions with negative follow-up for a minimum of 24 months
At least two orthogonal views of a lesion

Key exclusion criteria (6 listed)

Breast lesion images acquired after biopsy or surgery.
Any breast surgeries or interventional procedures in the 12 months prior to ultrasound imaging
Case demonstrating administrative or technical errors
Multiple lesions in one 2-D ultrasound image
Breast ultrasound images with Doppler, elastography, or other overlays present

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
Reader Group X - Session 1Each rater in "Reader Group X" will interpret the "dataset A" cases in different random order without BR-USCAD DS and interpret the "dataset B" cases in different random order with BR-USCAD DS.	Diagnostic test	First session: manual review first and then review with CADx
Reader Group Y - Session 1Each rater in "Reader Group Y" will interpret the "dataset A" cases in different random order with BR-USCAD DS and interpret the "dataset B" cases in different random order without BR-USCAD DS.	Diagnostic test	First session: review with CADx first and then manual review
Reader Group X - Session 2Each rater in "Reader Group X" will interpret the "dataset A" cases in different random order with BR-USCAD DS and interpret the "dataset B" cases in different random order without BR-USCAD DS.	Diagnostic test	Second session: manual review first and then review with CADx
Reader Group Y - Session 2Each rater in "Reader Group Y" will interpret the "dataset A" cases in different random order without BR-USCAD DS and interpret the "dataset B" cases in different random order with BR-USCAD DS.	Diagnostic test	Second session: review with CADx first and then manual review

Primary outcome

Comparing the Area Under the LROC Curve
Time frame: 10 weeks
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.

2 secondary outcomes

The Reading Time Was Computed and Compared for Aim 1 (Baseline) and Arm 2 (With BU-CAD Assistance) Studies.
Time frame: 10 weeks
The Sensitivity, Specificity, PPV, and NPV Were Computed and Compared for Aim 1 (Baseline) and Arm 2 (With BU-CAD Assistance) Studies.
Time frame: 10 weeks

Results and safety

Results posted to the registry on 2 Nov 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 1	8	8
Arm2	8	8

Primary outcome: Comparing the Area Under the LROC Curve

Time frame: 10 weeks. Mean (95% Confidence Interval). Unit: probability

Measure	Arm 1 n = 16	Arm 2 n = 16
Value	0.7786 (0.7463 to 0.8109)	0.8160 (0.7862 to 0.8458)

Arm 1 vs Arm 2: different in area under the LROC curve: 0.0374 (95% CI 0.0190 to 0.0557), p <0.05, OR-DBM model

Population analysed: Of the study breast ultrasound cases, some contained malignant lesions and some contained breast contained benign lesions.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events cannot be monitored/assessed. Because this is a retrospective reader study, not a human trial.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events
First Session: Manual Review First and Then Review With CADx	0 of 0	0 of 0
First Session: Review With CADx First and Then Manual Review	0 of 0	0 of 0
Second Session: Manual Review First and Then Review With CADx	0 of 0	0 of 0
Second Session: Review With CADx First and Then Manual Review	0 of 0	0 of 0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Not yet recruitingObservational study
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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.

Shih Chung Lo, Ph.D. study director

Arlington Innovation Center: Health Research - Virginia Tech

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 6 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: finished, as of the sponsor's last update on 2 Nov 2022. 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 2 Nov 2022). 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?

Comparing the Area Under the LROC Curve (time frame: 10 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04551105.

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 2 Nov 2022.