Ultrasound Technologies for Post-Reconstruction Breast Cancer Screening
Recruiting in Palo Alto (17 mi)
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.
12345Is 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.
14678How 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.
247910Eligibility 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.
+4 more
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.
+2 more
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
Participant Groups
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.
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.
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityPhiladelphia, PA
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Who Is Running the Clinical Trial?
Thomas Jefferson UniversityLead Sponsor
References
[Automated breast ultrasound vs. handheld ultrasound: BI-RADS classification, duration of the examination and patient comfort]. [2016]Automated breast ultrasound (ABUS) is a potentially valuable adjunct to mammography in breast cancer screening. The reliability and the inter-observer variability in the BI-RADS classification, compared to handheld ultrasound (US), as well as the duration of the examination and patient comfort have only been investigated in a limited number of papers to date.
Inter-rater reliability and double reading analysis of an automated three-dimensional breast ultrasound system: comparison of two independent examiners. [2019]Breast ultrasound could be a valuable tool complementary to mammography in breast cancer screening. Automated 3D breast ultrasound (ABUS) addresses challenges of hand-held ultrasound and could allow double reading analysis of ultrasound images. This trial assesses the inter-rater reliability and double reading analysis of an ABUS system.
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]The idea of an automated whole breast ultrasound was developed three decades ago. We present our initial experiences with the latest technical advance in this technique, the automated breast volume scanner (ABVS) ACUSON S2000(™). Volume data sets were collected from 50 patients and a database containing 23 women with no detectable lesions in conventional ultrasound (BI-RADS(®)-US 1), 13 women with clearly benign lesions (BI-RADS(®)-US 2), and 14 women with known breast cancer (BI-RADS(®)-US 5) was created. An independent examiner evaluated the ABVS data on a separate workstation without any prior knowledge of the patients' histories. The diagnostic accuracy for the experimental ABVS was 66.0% (95% confidence interval [CI]: 52.9-79.1). The independent examiner detected all breast cancers in the volume data resulting in a calculated sensitivity of 100% in the described setting (95% CI: 73.2%-100%). After the ABVS examination, there were a high number of requests for second-look ultrasounds in 47% (95% CI: 30.9-63.5) of the healthy women (with either a clearly benign lesion or no breast lesions at all in conventional handheld ultrasound). Therefore, the specificity remained at 52.8% (95% CI: 35.7-69.2). When comparing the concordance of the ABVS with the gold standard (conventional handheld ultrasound), Cohen's Kappa value as an estimation of the inter-rater reliability was κ = 0.37, indicating fair agreement. In conclusion, the ABVS must still be regarded as an experimental technique for breast ultrasound, which definitely needs to undergo further evaluation studies.
Automated Breast Volumetric Sonography Compared with Magnetic Resonance Imaging in Jewish BRCA 1/2 Mutation Carriers. [2017]Automated breast volumetric sonography (ABVS) is a new technology with various possible applications.
Diagnostic performance and inter-observer concordance in lesion detection with the automated breast volume scanner (ABVS). [2022]Automated whole breast ultrasound scanners of the latest generation have reached a level of comfortable application and high quality volume acquisition. Nevertheless, there is a lack of data concerning this technology. We investigated the diagnostic performance and inter-observer concordance of the Automated Breast Volume Scanner (ABVS) ACUSON S2000™ and questioned its implications in breast cancer diagnostics.
Automated breast ultrasound: basic principles and emerging clinical applications. [2020]Automated breast ultrasound (ABUS) is a recently introduced ultrasonography technique, developed with the purpose to standardize breast ultrasonography and overcome some limitations of handheld ultrasound (HHUS), such as operator dependence and the considerable amount of medical time necessary to perform and interpret HHUS. This new ultrasonography technique separates the moment of image acquisition (that may be performed also by a technician) from that of its interpretation, increasing reproducibility, reducing operator-dependence and physician time. Moreover, multiplanar reconstructions, especially the coronal view, introduce new diagnostic information. ABUS, with those advantages, has the potential to be used as an adjunctive tool to screening mammography, especially in the dense breast, where mammography has a relatively low sensitivity. Women's awareness of risks related to breast density is a hot topic, especially in the USA where legislative breast density notification laws increase the demand for supplemental ultrasound screening. Therefore, ABUS might have the potential to respond to this need. The purpose of this article is to present a summary of current state-of-the-art of ABUS technology and applications, with an emphasis on breast cancer screening. This article discusses also how to overcome some ABUS limitations, in order to be familiar with the new technique.
Diagnostic performance of coronal view in comparison with transverse view of three-dimensional automated breast ultrasound. [2021]Automated breast ultrasound (ABUS) is one of the first ultrasound devices which enables the de-coupling of image acquisition and interpretation. Another feature of ABUS is the coronal view, utilizing three-dimensional volume data reconstructed from two-dimensional transverse images acquired automatically.
Current status of automated breast ultrasonography. [2022]Breast ultrasonography (US) is currently considered the first-line examination in the detection and characterization of breast lesions. However, conventional handheld US (HHUS) has several limitations such as operator dependence and the requirement of a considerable amount of radiologist time for whole-breast US. Automated breast US (ABUS), recently approved by the United States Food and Drug Administration for screening purposes, has several advantages over HHUS, such as higher reproducibility, less operator dependence, and less required physician time for image acquisition. In addition, ABUS provides both a coronal view and a relatively large field of view. Recent studies have reported that ABUS is promising in US screening for women with dense breasts and can potentially replace handheld second-look US in a preoperative setting.
The efficacy of automated breast volume scanning over conventional ultrasonography among patients with breast lesions. [2016]To compare the efficacy of automated breast volume scanning (ABVS) with that of conventional ultrasonography in the detection of breast cancer lesions.
[Automated breast volume scanner (ABVS) : a new approach for breast imaging]. [2022]The automated breast ultrasound technique has been known for a long time but did not play an important role in diagnostics due to its inferior sensitivity for small solid lesions with low frequency transducers and its uncomfortable examination technique with the patients in a supine position and the breast immersed in water. The automated breast volume scanner (AVBS) is a high-end ultrasound scanner which employs frequencies of 5-14 MHz and consists of a flexible arm with the transducer at the end, a touchscreen and a 3D workstation. The scan is performed with the patient in the prone position. Depending on the breast size, various presettings are available from which the examiner may select the most appropriate. AVBS has various major advantages, such as being independent from the experience of the operator as well as supplying consistent and reproducible results. Additionally, for the first time it became possible to obtain coronal images of the complete breast, which greatly assists the planning of surgical interventions. In this article the ABVS technique will be described and results will be illustrated by means of clinical examples.