BreastACCRUENCT03052166
Case Collection Study to Determine the Accuracy, Call Back and Cancer Detection Rates of QT Ultrasound in Breast Imaging
An observational study of Breast, run by QT Ultrasound LLC at 2 sites in United States.
Trial summary
Brief Summary: The QT Ultrasound system is an automated scanner which transmits pulsed ultrasound plane waves through the breast, as well as collects reflected ultrasound output. As the patient lays prone on a table, the breast is submerged in a warm water bath. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast
- What is being tested?
- QT Ultrasound scan
- Type of treatment
- Medical device
- How many people
- 755 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Apr 2017to 1 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- Adult, Older adult
Study population: Women, age 18 and older
Who may be able to join
- Female
- Age 18 or older
- Willing to receive a QT Ultrasound Breast Scan
- Willing and able to provide written Informed Consent prior to any research-related procedure(s)
- Cohort A and B Subjects that do not meet these Inclusion Criteria will be evaluated for Inclusion in Cohort C
- Eligible for routine screening mammography as per ACR guidelines
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- Willing and able to submit or complete at the clinical site a Digital Mammography with Digital Breast Tomosynthesis exam (to include Craniocaudal (CC) and Mediolateral Oblique (MLO) views - for one or both breasts, within 3 months, before or after, their QT scan.
- Cohort C
- 1. Willing and able to submit available breast imaging - for one or both breasts, before or after, their QT scan.
Who cannot join
- Pregnancy
- Currently breastfeeding
- Allergies to device materials
- Physical inability to tolerate the procedure on the scanner, i.e. inability to lie prone and still for up to 30 minutes at a time
- Open wounds, sores or skin rash present on the breast(s) or nipple discharge from the scanned breast
- Breasts too large for scanner, i.e. inability to successfully "fit" breast after the subject is placed on scanner
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- Body weight greater than 400 lbs. (180 kg)
- Has a concurrent disease or condition which in the judgment of the Principal Investigator disqualifies the subject, from participating in the study
- Magnetic material in the chest which in the judgement of the Principal Investigator would interfere with or be impacted by the magnets within the study device.
- Cohort A and B Subjects that meet any of these conditions below will not be eligible for Cohort A or B and will be evaluated for eligibility in Cohort C.
- History of breast cancer in the past 12 months.
- Most recent screening mammography exam was completed more than 3 months but less than 11 months prior.
- History of breast surgeries or interventional breast procedures in the past 12 months, except for Fine Needle Aspiration(s) or Cyst Aspiration(s)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Memorial Care Long Beach
Long Beach, California, 90806
Marin Breast Health Trial Center
Novato, California, 94949
About this study
Official title: A Prospective Multi-center Case Collection Study of Breast Imaging Examinations From Women to Evaluate the Non-inferiority of QT Ultrasound Compared to Digital Mammography-Digital Breast Tomography (DM-DBT)
Brief Summary: The QT Ultrasound system is an automated scanner which transmits pulsed ultrasound plane waves through the breast, as well as collects reflected ultrasound output. As the patient lays prone on a table, the breast is submerged in a warm water bath. The transmitter and receiver assembly moves around the suspended breast to record data for successive sub-volumes of targeted tissue. More than 2000 elements in the curvilinear transducer's array encircle the breast to gather data from the tissue structures of the breast, from nipple to chest wall. Information gathered from this automated QT scan encompasses the entire breast which is currently not commercially available using any other ultrasound technology.
Read the detailed description
This is a prospective, multicenter, multi-arm case collection study, with IRB approval. The study will follow an adaptive design with an initially planned total enrollment of approximately 600 cases to include both benign and malignant cases, representative of all tissue densities.
The images and clinical data accrued in this prospective case collection will be used for creation of a database to facilitate future reader's studies, publications, building teaching files, and future marketing for QT Ultrasound.
- Conditions
- Breast
- Being tested
- QT Ultrasound scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QT Ultrasound scanDevice
QT Ultrasound scan
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | The group of asymptomatic subjects who have been given BI-RADS 1 or 2 based on their most recent standard of care assessment. All subjects will receive a QT Ultrasound scan. Receives: Device: QT Ultrasound scan | |
| Cohort B | The group of asymptomatic women who have been given BI-RADS categories 4 or 4a, 4b, 4c or 5 based on their most recent standard of care assessment. All subjects will receive a QT Ultrasound scan. Receives: Device: QT Ultrasound scan | |
| Cohort C | The group of women who have been given BI-RADS categories 1, 2, 3, 4 or (4a, 4b, 4c), 5 or 6 based on their most recent standard of care assessment. All subjects will receive a QT Ultrasound scan. Subjects are assigned to Cohort C when it has been determined they cannot be assigned to Cohort A or Cohort B. Receives: Device: QT Ultrasound scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of QT Ultrasound to DM-DBT
Non-inferiority evaluation of sensitivity, specificity, positive predictive value and non-cancer recall rate.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study start18 Apr 2017
- Primary completion31 Dec 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BreastStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 755 participants (actual)
Sponsor and investigators
- Lead sponsor
- QT Ultrasound LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03052166
- Sponsor's protocol ID
- BR005
- Acronym
- ACCRUE
- Status last verified
- Mar 2021
- First submitted
- 7 Feb 2017
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Malik B, Chen JH, Su MY, Wiskin J, Iuanow E. Volumetric Quantification of Breast Tissue Composition Using Transmission Ultrasound: A Validation Study Against MRI. Ultrasound Med Biol. 2026 Aug 13:S0301-5629(26)00294-2. doi: 10.1016/j.ultrasmedbio.2026.07.020. Online ahead of print.
PubMed 42595593
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multi-center Case Collection Study of Breast Imaging Examinations From Women to Evaluate the Non-inferiority of QT Ultrasound Compared to Digital Mammography-Digital Breast Tomography (DM-DBT)
- ClinicalTrials.gov ID
- NCT03052166
- Acronym / sponsor ID
- ACCRUE / BR005
- Conditions
- Breast
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 755 participants (actual)
- Lead sponsor
- QT Ultrasound LLCIndustry (pharma, biotech, devices)
- Study start
- 18 Apr 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 14 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Brief Summary: The QT Ultrasound system is an automated scanner which transmits pulsed ultrasound plane waves through the breast, as well as collects reflected ultrasound output. As the patient lays prone on a table, the breast is submerged in a warm water bath. The transmitter and receiver assembly moves around the suspended breast to record data for successive sub-volumes of targeted tissue. More than 2000 elements in the curvilinear transducer's array encircle the breast to gather data from the tissue structures of the breast, from nipple to chest wall. Information gathered from this automated QT scan encompasses the entire breast which is currently not commercially available using any other ultrasound technology.
Detailed description
This is a prospective, multicenter, multi-arm case collection study, with IRB approval. The study will follow an adaptive design with an initially planned total enrollment of approximately 600 cases to include both benign and malignant cases, representative of all tissue densities.
The images and clinical data accrued in this prospective case collection will be used for creation of a database to facilitate future reader's studies, publications, building teaching files, and future marketing for QT Ultrasound.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Device: QT Ultrasound scanThe group of asymptomatic subjects who have been given BI-RADS 1 or 2 based on their most recent standard of care assessment. All subjects will receive a QT Ultrasound scan. |
| Cohort B | – | Device: QT Ultrasound scanThe group of asymptomatic women who have been given BI-RADS categories 4 or 4a, 4b, 4c or 5 based on their most recent standard of care assessment. All subjects will receive a QT Ultrasound scan. |
| Cohort C | – | Device: QT Ultrasound scanThe group of women who have been given BI-RADS categories 1, 2, 3, 4 or (4a, 4b, 4c), 5 or 6 based on their most recent standard of care assessment. All subjects will receive a QT Ultrasound scan. Subjects are assigned to Cohort C when it has been determined they cannot be assigned to Cohort A or Cohort B. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Women, age 18 and older
Key inclusion criteria (9 listed)
- Female
- Age 18 or older
- Willing to receive a QT Ultrasound Breast Scan
- Willing and able to provide written Informed Consent prior to any research-related procedure(s)
- Cohort A and B Subjects that do not meet these Inclusion Criteria will be evaluated for Inclusion in Cohort C
Key exclusion criteria (13 listed)
- Pregnancy
- Currently breastfeeding
- Allergies to device materials
- Physical inability to tolerate the procedure on the scanner, i.e. inability to lie prone and still for up to 30 minutes at a time
- Open wounds, sores or skin rash present on the breast(s) or nipple discharge from the scanned breast
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 |
|---|---|---|
| QT Ultrasound scanQT Ultrasound scan | Device | Cohort A, Cohort B, Cohort C |
Primary outcome
Comparison of QT Ultrasound to DM-DBT
Time frame: 12 months
Non-inferiority evaluation of sensitivity, specificity, positive predictive value and non-cancer recall rate.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Derived from this study: PubMed 42595593Malik B, Chen JH, Su MY, Wiskin J, Iuanow E. Volumetric Quantification of Breast Tissue Composition Using Transmission Ultrasound: A Validation Study Against MRI. Ultrasound Med Biol. 2026 Aug 13:S0301-5629(26)00294-2. doi: 10.1016/j.ultrasmedbio.2026.07.020. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast, run by QT Ultrasound LLC at 2 sites in United States.
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 9 inclusion and 13 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 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Comparison of QT Ultrasound to DM-DBT (time frame: 12 months). 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 NCT03052166, which also lists 1 linked publication.
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 18 Mar 2021.