Clinical trial · Observational
Simulated Screening Study for Breast Imaging
Simulated Screening Study of Combined Digital X-Ray, Ultrasound and Photoacoustic Breast Imaging
NCT01807754CI-TRIAL-00045195completedClinicalTrials.gov clinicaltrialsProvenance
- 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)
This is a pilot, simulated breast cancer screening study. The goal of the study is to explore these scanning modalities: 1\) Combined digital breast tomosynthesis(DBT)/dual-sides 3 dimensional-automated ultrasound(AUS) 2\. Explore the utility of photoacoustic imaging as an adjunct to digital breast tomosynthesis(DBT)/ultrasound(US)alone.
Conditions
Conditions (2)
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 Cysts | — | UNRESOLVED | — |
| Breast Tumors | Breast Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Photoacoustic imaging scans for breast cancer screening | Procedure | — | UNRESOLVED |
| X-ray and ultrasound imaging scanning | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Imaging scans for breast cancer screening
- description
- To simulate the performance of the combination of three new breast imaging systems to digital mammography and hand-held ultrasound that are currently used to find and evaluate breast masses. These three different systems make images of the breast in several ways to find breast masses and to distinguish normal and abnormal masses. This may result in less unnecessary call-backs from mammography.
- interventionNames
- Procedure: X-ray and ultrasound imaging scanning
- Procedure: Photoacoustic imaging scans for breast cancer screening
Primary outcomes (1)
- measure
- Evaluation of new breast imaging devices
- timeFrame
- 3 years
- description
- To determine if photoacoustic imaging is an adjunct to standard of care imaging with regards to quality of imaging. and ultrasound modalities and to determine if combining digital breast tomosynthesis and 3 dimensional automated ultrasound will result in a lower call-back ratio than imaging with digital breast tomosynthesis alone.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Women with possible masses * All women should have had mammograms at University of Michigan Health System within 1 year before this research study. Exclusion Criteria: * Women who are physically unable to tolerate the length of the scan. * Women who are less than 30 years of age or older than 80 years of age * Women who are pregnant or lactating * Women whose mass is in an area of the breast which makes it difficult to see in the research scans * Womens with a single diagnosis of mammographic calcifications * Women who have had a breast cancer with lumpectomy * Women who are prisoners * Women who are students or staff of investigators * Women who cannot give consent * Women with mammograms classified as probably benign because of follow-up of a recent benign biopsy. * Women with breast pain who have been categorized as BIRADS(Breast Imaging Reporting and Data System) category 0(incomplete) on their most recent mammograms. * Males, because their breast tissue is not easily imaged and numbers of potential cases are too few.
References
Publications (0)
Data not yet available
No reference posted for this study.