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Ultrasound Technologies for Post-Reconstruction Breast Cancer Screening

Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Thomas Jefferson University
Disqualifiers: Breast cancer recurrence, Pregnant, others
No Placebo Group

Trial Summary

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.

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?

Automated breast ultrasound (ABUS) is considered safe for humans and has been approved by the United States Food and Drug Administration for breast cancer screening. It offers advantages like higher reproducibility and less operator dependence compared to traditional handheld ultrasound.14678

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

Research Team

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

I can understand and sign the consent form, or have someone legally authorized to do so on my behalf.
Willing to comply with all study procedures and be available for the duration of the study
I had breast surgery with implant or flap reconstruction at Thomas Jefferson University Hospital.
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Exclusion Criteria

I had both breasts surgically removed with immediate reconstruction.
I have breast symptoms after nipple-sparing or skin-sparing mastectomy with reconstruction.
I had a nipple-sparing or skin-sparing mastectomy with reconstruction before.
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Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Ultrasound Evaluation

Participants undergo HHUS and ABUS to evaluate the detection of residual tissue in reconstructed mastectomy patients

1 hour
1 visit (in-person)

Biopsy (if needed)

Participants with BI-RADS 4 or 5 results undergo biopsy

Within 30 days

Follow-up

Participants are monitored for safety and effectiveness after ultrasound evaluation

Up to 1 year

Treatment Details

Interventions

  • Automated Breast Ultrasound (Procedure)
  • Ultrasonography (Procedure)
Trial OverviewThe study compares two ultrasound technologies: Automated Breast Ultrasound (ABUS) and Handheld Ultrasound (HHUS), to see which is better for screening women with reconstructed breasts after breast cancer treatment.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Screening (automated breast ultrasound, handheld ultrasound)Experimental Treatment2 Interventions
Participants undergo HHUS and ABUS in no required order over 1 hour.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials
475
Recruited
189,000+
Dr. Eugene Kennedy profile image

Dr. Eugene Kennedy

Thomas Jefferson University

Chief Medical Officer since 2020

MD

Dr. Joseph G. Cacchione profile image

Dr. Joseph G. Cacchione

Thomas Jefferson University

Chief Executive Officer since 2022

MD, MBA

Findings from Research

Automated breast ultrasound (ABUS) shows high inter-observer agreement in BI-RADS classification (κ = 0.750), indicating reliable results among different evaluators, which is better than the moderate agreement seen with handheld ultrasound.
The sensitivity for detecting breast cancer was comparable between ABUS and handheld ultrasound, with ABUS showing 75% sensitivity compared to 87.5% for handheld ultrasound, suggesting that ABUS is a viable alternative for breast cancer screening.
[Automated breast ultrasound vs. handheld ultrasound: BI-RADS classification, duration of the examination and patient comfort].Prosch, H., Halbwachs, C., Strobl, C., et al.[2016]
The automated 3D breast ultrasound system (SomoV™) demonstrated fair inter-rater reliability with an agreement rate of 81.6% among two examiners, indicating it can be reliably used for breast cancer screening.
When combined with mammography, SomoV™ increased the overall sensitivity for detecting breast cancer from 90.1% to 97.7%, suggesting it could significantly enhance cancer detection rates in screening programs.
Inter-rater reliability and double reading analysis of an automated three-dimensional breast ultrasound system: comparison of two independent examiners.Maier, A., Heil, J., Lauer, A., et al.[2019]
The automated breast volume scanner (ABVS) demonstrated a high sensitivity of 100% in detecting breast cancer among 50 patients, indicating its potential effectiveness in identifying malignancies.
However, the ABVS had a lower specificity of 52.8%, leading to a significant number of unnecessary follow-up ultrasounds in healthy women, suggesting that while promising, the technique requires further evaluation before it can be considered a reliable diagnostic tool.
The Automated Breast Volume Scanner (ABVS): initial experiences in lesion detection compared with conventional handheld B-mode ultrasound: a pilot study of 50 cases.Wojcinski, S., Farrokh, A., Hille, U., et al.[2022]

References

[Automated breast ultrasound vs. handheld ultrasound: BI-RADS classification, duration of the examination and patient comfort]. [2016]
Inter-rater reliability and double reading analysis of an automated three-dimensional breast ultrasound system: comparison of two independent examiners. [2019]
The Automated Breast Volume Scanner (ABVS): initial experiences in lesion detection compared with conventional handheld B-mode ultrasound: a pilot study of 50 cases. [2022]
Automated Breast Volumetric Sonography Compared with Magnetic Resonance Imaging in Jewish BRCA 1/2 Mutation Carriers. [2017]
Diagnostic performance and inter-observer concordance in lesion detection with the automated breast volume scanner (ABVS). [2022]
Automated breast ultrasound: basic principles and emerging clinical applications. [2020]
Diagnostic performance of coronal view in comparison with transverse view of three-dimensional automated breast ultrasound. [2021]
Current status of automated breast ultrasonography. [2022]
The efficacy of automated breast volume scanning over conventional ultrasonography among patients with breast lesions. [2016]
[Automated breast volume scanner (ABVS) : a new approach for breast imaging]. [2022]