Ultrasound Technologies for Post-Reconstruction Breast Cancer Screening
Trial Summary
Do I need to stop my current medications for this trial?
The trial protocol does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Automated Breast Ultrasound (ABUS) and Automated Breast Volume Scanner (ABVS) for post-reconstruction breast cancer screening?
Research shows that Automated Breast Volume Scanner (ABVS) has a high sensitivity of 100% for detecting breast cancer in a specific study setting, meaning it successfully identified all breast cancer cases in the study. However, its specificity, which measures the ability to correctly identify those without the disease, was lower at 52.8%, indicating a need for further evaluation.12345
Is automated breast ultrasound (ABUS) safe for humans?
How is the treatment Automated Breast Ultrasound different from other treatments for post-reconstruction breast cancer screening?
Automated Breast Ultrasound (ABUS) is unique because it allows for consistent and reproducible imaging that is less dependent on the operator's experience, and it provides a comprehensive coronal view of the breast, which is not possible with traditional ultrasound methods. This technology also enables the separation of image acquisition from interpretation, potentially improving diagnostic accuracy.247910
What is the purpose of this trial?
This clinical trial evaluates automated breast ultrasound (ABUS) and handheld ultrasound (HHUS) for the screening of women who have undergone breast reconstruction after breast cancer. Ultrasounds use high-frequency sound waves to create pictures of internal organs and tissues. ABUS has been found to be equal to HHUS for whole breast screening, but no data exist on its use for screening of reconstructed patients. This clinical trial evaluates the feasibility of using ABUS versus HHUS to screen women who have undergone reconstruction.
Eligibility Criteria
This trial is for women over 18 who've had breast reconstruction after cancer. They should have no current breast symptoms or history of recurrence, and must not be pregnant. The surgery must have been within the last five years at Thomas Jefferson University Hospital.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Ultrasound Evaluation
Participants undergo HHUS and ABUS to evaluate the detection of residual tissue in reconstructed mastectomy patients
Biopsy (if needed)
Participants with BI-RADS 4 or 5 results undergo biopsy
Follow-up
Participants are monitored for safety and effectiveness after ultrasound evaluation
Treatment Details
Interventions
- Automated Breast Ultrasound
- Ultrasonography
Automated Breast Ultrasound is already approved in United States, European Union for the following indications:
- Supplemental breast cancer screening in women with dense breasts
- Supplemental breast cancer screening in women with dense breasts
Find a Clinic Near You
Who Is Running the Clinical Trial?
Thomas Jefferson University
Lead Sponsor