Ultrasound Technologies for Post-Reconstruction Breast Cancer Screening

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Thomas Jefferson University

Disqualifiers: Breast cancer recurrence, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of ultrasound—ABUS (automated breast ultrasound) and HHUS (handheld ultrasound)—to evaluate their effectiveness in screening women who have undergone breast reconstruction after breast cancer. Ultrasounds use sound waves to create images of the body's interior. Researchers aim to determine if ABUS can match the effectiveness of HHUS for these patients. Women who have had one breast reconstructed with an implant or flap at Thomas Jefferson University Hospital and have no current breast issues may qualify for this trial.

As an unphased trial, this study allows participants to contribute to research that could enhance screening methods for women with reconstructed breasts.

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 prior data suggests that these ultrasound technologies are safe for post-reconstruction breast cancer screening?

Research has shown that ultrasound technologies, such as Automated Breast Ultrasound (ABUS) and handheld ultrasound (HHUS), are safe for breast cancer screening. ABUS reliably detects breast cancer, particularly in women with dense breast tissue, and is well-tolerated.

Both ABUS and HHUS use sound waves to create images of breast tissue. This technique avoids radiation, making it safer than some other imaging methods. Studies have found no harmful side effects from these ultrasound procedures.

The FDA also recommends ultrasound for checking breast implants, further supporting its safety. Thus, both ABUS and HHUS are considered safe and non-invasive options for breast cancer screening. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using ultrasound technologies for post-reconstruction breast cancer screening because they offer a non-invasive, radiation-free alternative to traditional mammography. Unlike standard techniques, automated breast ultrasound (ABUS) and handheld ultrasound (HHUS) can provide a clearer view of dense breast tissues, which is often a challenge with regular mammograms. These methods could lead to earlier detection of potential issues, improving outcomes for patients who have undergone reconstruction.

What evidence suggests that these ultrasound technologies are effective for post-reconstruction breast cancer screening?

Research shows that automated breast ultrasound (ABUS) effectively screens for breast cancer, particularly in women with dense breast tissue. Combining ABUS with traditional methods improves cancer detection rates. One study found that ABUS detected breast cancer in all patients tested, suggesting high reliability. In this trial, participants will undergo both ABUS and handheld ultrasound (HHUS) as part of the screening process. For HHUS, the results are also promising. Studies indicate that HHUS can detect recurring cancer in patients who have had a mastectomy, although detection rates remain relatively low. These findings suggest that both ABUS and HHUS could be valuable tools for breast screening after reconstruction. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Automated Breast Ultrasound
• Ultrasonography

Trial Overview The 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.

How Is the Trial Designed?

Group I: Screening (automated breast ultrasound, handheld ultrasound) Experimental Treatment 2 Interventions

Participants undergo HHUS and ABUS in no required order over 1 hour.

Automated Breast Ultrasound is already approved in United States, European Union for the following indications:

Approved in United States as ABUS for:

• Supplemental breast cancer screening in women with dense breasts

Approved in European Union as ABUS for:

• Supplemental breast cancer screening in women with dense breasts

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Automated breast ultrasound (ABUS) improves the standardization and reproducibility of breast imaging by separating image acquisition from interpretation, which reduces operator dependence and medical time required for assessments.

ABUS has the potential to enhance breast cancer screening, particularly in women with dense breast tissue, where traditional mammography may be less effective, thus addressing the growing demand for supplemental ultrasound screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated breast ultrasound: basic principles and emerging clinical applications. Zanotel, M., Bednarova, I., Londero, V., et al.[2020]

In a study involving 68 Jewish female BRCA1/2 mutation carriers, automated breast volumetric sonography (ABVS) showed only slight agreement with breast MRI in detecting breast abnormalities, indicating that ABVS may be less effective than MRI for surveillance in this high-risk group.

Among the 79 paired examinations, there was one case of cancer detected by MRI that was missed by ABVS, highlighting the potential limitations of ABVS in accurately identifying malignancies compared to MRI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated Breast Volumetric Sonography Compared with Magnetic Resonance Imaging in Jewish BRCA 1/2 Mutation Carriers. Halshtok Neiman, O., Erlich, Z., Friedman, E., et al.[2017]

Automated breast volume scanning (ABVS) detected 417 breast lesions in a study of 300 patients, significantly outperforming conventional ultrasonography, which identified only 326 lesions (P<0.001).

ABVS was able to detect all 32 malignant lesions, while conventional ultrasonography detected 31, and it also identified more microcalcifications (8 cases vs. 2 cases), highlighting its superior efficacy in breast cancer detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of automated breast volume scanning over conventional ultrasonography among patients with breast lesions. Xiao, YM., Chen, ZH., Zhou, QC., et al.[2016]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[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 Breast Volume Scanner (ABVS) demonstrated a diagnostic accuracy of 79.0% with a sensitivity of 83.3% and specificity of 78.1%, indicating it is a reliable method for breast evaluation, particularly in detecting malignant cases.

Despite its effectiveness, the ABVS produced a high rate of false positives, leading to nearly 49% of healthy women requiring additional ultrasound examinations, highlighting the need for further studies to refine its use in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic performance and inter-observer concordance in lesion detection with the automated breast volume scanner (ABVS). Wojcinski, S., Gyapong, S., Farrokh, A., et al.[2022]

The use of the coronal view in automated breast ultrasound (ABUS) significantly improved diagnostic performance for detecting malignancies, with an area under the curve of 0.917 compared to 0.856 for the transverse view, based on a study of 100 scan datasets.

Reading times for interpreting coronal and transverse views were similar, suggesting that the coronal view can enhance accuracy without significantly increasing the time needed for analysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic performance of coronal view in comparison with transverse view of three-dimensional automated breast ultrasound. Suzuki, M., Nakayama, R., Namba, K., et al.[2021]

The automated breast volume scanner (AVBS) offers improved sensitivity for detecting small solid lesions due to its use of higher frequency transducers (5-14 MHz) and allows for consistent results regardless of the operator's experience.

AVBS enables patients to be scanned in a prone position, providing coronal images of the entire breast, which enhances surgical planning and addresses previous discomfort associated with traditional ultrasound techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Automated breast volume scanner (ABVS) : a new approach for breast imaging]. Wöhrle, NK., Hellerhoff, K., Notohamiprodjo, M., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Automated breast ultrasonography (ABUS) is now FDA-approved for screening and offers advantages over conventional handheld ultrasonography (HHUS), including higher reproducibility and less operator dependence, which can save time for radiologists.

ABUS is particularly promising for screening women with dense breasts and may serve as a replacement for handheld second-look ultrasonography in preoperative assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current status of automated breast ultrasonography. Shin, HJ., Kim, HH., Cha, JH.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8400952/

Pros and Cons for Automated Breast Ultrasound (ABUS) ABUS is a standardized examination with many advantages in both screening and diagnostic settings: it increases the detection rate of breast cancer, improves ...

2. ajronline.org ajronline.org/doi/10.2214/AJR.15.15367

Automated Breast Ultrasound in Breast Cancer Screening of ... Combining mammography with ABUS, compared with mammography alone, significantly improved readers' detection of breast cancers in women with dense breast tissue.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0301562923003125

Automated Breast Ultrasound Provides Comparable ... The aim of the work described here was to assess the performance of automated breast ultrasound (ABUS) as an adjunct to digital breast tomosynthesis (DBT)

4. withpower.com withpower.com/trial/phase-breast-neoplasms-5-2022-89192

Ultrasound Technologies for Post-Reconstruction Breast ... The automated breast volume scanner (ABVS) demonstrated a high sensitivity of 100% in detecting breast cancer among 50 patients, indicating its potential ...

5. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/rg.230023

Pearls and Pitfalls of Interpretation of Automated Breast US The goals of this article are to (a) examine the role of AUS as a supplemental screening modality and (b) review the pearls and pitfalls of AUS interpretation.

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf11/P110006b.pdf

FDA - Summary of Safety and Effectiveness Data (SSED) The 3D ultrasound dataset is available to the reader immediately after acquisition and at any future point in the course of a patient's care.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3221417/

The Automated Breast Volume Scanner (ABVS) Volume data sets were collected from 50 patients and a database containing 23 women with no detectable lesions in conventional ultrasound (BI- ...

8. nature.com nature.com/articles/s41598-023-41424-7

Cost-effective, portable, patient-dedicated three- ... We developed and validated a cost-effective, portable, patient-dedicated three-dimensional (3D) automated breast ultrasound (ABUS) system for point-of-care ...