Ultrasound Technologies for Post-Reconstruction Breast Cancer Screening
Palo Alto (17 mi)Age: 18+
Sex: Female
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: Thomas Jefferson University
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.
What safety data exists for automated breast ultrasound technologies?The research does not explicitly mention safety data for automated breast ultrasound (ABUS) technologies. However, ABUS has been approved by the United States Food and Drug Administration for screening purposes, indicating a level of safety and efficacy. The studies highlight ABUS's advantages over handheld ultrasound, such as higher reproducibility, less operator dependence, and reduced physician time, which may indirectly suggest safety benefits. ABUS is also noted for its potential use in women with dense breasts, where traditional mammography is less effective.257910
Is the treatment Automated Breast Ultrasound a promising treatment for breast cancer screening after reconstruction?Yes, Automated Breast Ultrasound (ABUS) is promising because it provides consistent and reproducible results, doesn't rely on the operator's experience, and offers detailed 3D images that help in planning surgeries. It can also be used alongside mammography to improve breast cancer screening.167810
What data supports the idea that Ultrasound Technologies for Post-Reconstruction Breast Cancer Screening is an effective treatment?The available research shows that Ultrasound Technologies, like the Automated Breast Volume Scanner (ABVS), can effectively detect breast cancer. In one study, the ABVS detected all breast cancers in the test group, showing a sensitivity of 100%. However, it also had a high rate of false positives, leading to many unnecessary follow-up exams. Compared to traditional handheld ultrasound, ABVS offers a more automated and potentially more comfortable experience, but it still needs more research to confirm its reliability. Overall, while promising, ABVS is still considered experimental and needs further evaluation.23478
Do I have to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications. It seems unlikely that you would need to stop, as the trial focuses on ultrasound screening methods.
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 had breast surgery with implant or flap reconstruction at Thomas Jefferson University Hospital.
I am female.
I am 18 years old or older.
I have no breast lumps or unusual symptoms.
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 am currently pregnant.
My breast cancer has come back after treatment.
Treatment Details
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:
๐บ๐ธ Approved in United States as ABUS for:
- Supplemental breast cancer screening in women with dense breasts
๐ช๐บ 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 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.
[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.
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(โข). Volume data sets were collected from 50 patients and a database containing 23 women with no detectable lesions in conventional ultrasound (BI-RADS(ยฎ)-US 1), 13 women with clearly benign lesions (BI-RADS(ยฎ)-US 2), and 14 women with known breast cancer (BI-RADS(ยฎ)-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 ฮบ = 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.
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 S2000โข and questioned its implications in breast cancer diagnostics.
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 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.
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.
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.