Clinical trial · Observational
Case Collection Study to Determine the Accuracy, Call Back and Cancer Detection Rates of QT Ultrasound in Breast Imaging
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| QT Ultrasound scan | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Cohort A
- description
- 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.
- interventionNames
- Device: QT Ultrasound scan
- label
- Cohort B
- description
- 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.
- interventionNames
- Device: QT Ultrasound scan
- label
- Cohort C
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
INCLUSION CRITERIA All Subjects 1. Female 2. Age 18 or older 3. Willing to receive a QT Ultrasound Breast Scan 4. 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 1. Eligible for routine screening mammography as per ACR guidelines 2. 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. EXCLUSION CRITERIA All Subjects 1. Pregnancy 2. Currently breastfeeding 3. Allergies to device materials 4. 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 5. Open wounds, sores or skin rash present on the breast(s) or nipple discharge from the scanned breast 6. Breasts too large for scanner, i.e. inability to successfully "fit" breast after the subject is placed on scanner 7. Body weight greater than 400 lbs. (180 kg) 8. Has a concurrent disease or condition which in the judgment of the Principal Investigator disqualifies the subject, from participating in the study 9. 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. 1. History of breast cancer in the past 12 months. 2. Most recent screening mammography exam was completed more than 3 months but less than 11 months prior. 3. History of breast surgeries or interventional breast procedures in the past 12 months, except for Fine Needle Aspiration(s) or Cyst Aspiration(s)
References
Publications (1)
- DERIVEDMalik 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. PMID 42595593