Evaluation of the Bexa™ Breast Examination (BBE)

NCT05882019 | Unknown FDA Device

• 1 other identifier: Pro00067814
• Study Type: interventional
• Target: 700
• Locations: 0 countries
• Sites: N/A

Brief Summary

Objective The "Bexa Breast Exam," or "BBE," for the purposes of this study is defined as the use of a Bexa device in conjunction with a portable, focused ultrasound examination ("spot ultrasound") to identify and further evaluate abnormal breast masses including cancer. Commercially, this combination of Bexa plus focused ultrasound is called "Bexa Plus." This study compares the use of the Bexa Breast Exam (BBE/Bexa Plus) as a breast cancer early detection examination with the current standard of care digital breast tomosynthesis. The specific objectives are:

1. 1.To measure the sensitivity and specificity of BBE as compared to digital breast tomosynthesis.
2. 2.Measure the proportion of women receiving a Bexa Breast Exam that require additional imaging studies.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Bexa sensitivity of mass detection

  Bexa sensitivity of mass detection as compared to digital tomosynthesis mammography

  During procedure

Secondary Outcomes (2)

• False Negative Comparison between Bexa and Mammography

  During procedure

• Bexa Detected Breast Cancers

  8 weeks

Study Arms (1)

Breast Exam with Bexa

OTHER

Bexa exam to be performed on participants already scheduled for either screening or diagnostic mammography.

Device: Breast Exam with Bexa

Interventions

Breast Exam with Bexa DEVICE

Breast exam with Bexa uses pressure elastography to produce a map of the breast tissue's elasticity.

Breast Exam with Bexa

Eligibility Criteria

• Age: 30 Years - 80 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals who are scheduled for a diagnostic or screening mammogram.
• Patients of all races, ethnicities, and socio-economic background
• Signed informed consent obtained prior to any study assessments and procedures.
• Age 30-80 years of age and female.

You may not qualify if:

• Positive findings with a size in their greatest dimension \> 2cm as measured by ultrasound. These masses are frequently palpable if not overtly visible and our focus, and that of other modalities used in early detection, is primarily but not exclusively the identification of non-palpable masses.
• Positive findings that cause a visible and obvious deformity of the breast or alteration in the skin appearance of the breast.
• Women with breast tenderness significant enough to prevent completion of any of the study examinations. Both ultrasound and Bexa require a light degree of pressure on the breast; certain women, very few, have enough breast tenderness that they cannot tolerate the pressure of either Bexa or ultrasound.
• Women with breast surface scarring significant enough to prevent effective BBE (keloid scarring from a previous procedure on the breast, for example).
• Greater than 3 positive findings in a given breast.
• Women who are unable to comprehend or unwilling to sign an informed consent form.
• Women ages \< 30 and \> 80 years of age.
• Pregnant women.
• Women who have had mastectomy - unilateral or bilateral.
• Women who have had breast cancer within the last 2 years

Sponsors & Collaborators

• Sure, Inc.: lead
• MaineHealth: collaborator

Related Publications (4)

• Kaufman CS, et al., Objective measurement of the physical exam using a new device: reproducible triage of palpable masses. Breast Cancer Research and Treatment, 2004; 88; supp 1:S223-4- SABCS 2004.

  BACKGROUND

• Miglioretti DL, Lange J, van den Broek JJ, Lee CI, van Ravesteyn NT, Ritley D, Kerlikowske K, Fenton JJ, Melnikow J, de Koning HJ, Hubbard RA. Radiation-Induced Breast Cancer Incidence and Mortality From Digital Mammography Screening: A Modeling Study. Ann Intern Med. 2016 Feb 16;164(4):205-14. doi: 10.7326/M15-1241. Epub 2016 Jan 12.

  PMID: 26756460 RESULT

• National Center for Health Statistics (US). Health, United States, 2016: With Chartbook on Long-term Trends in Health. Hyattsville (MD): National Center for Health Statistics (US); 2017 May. Report No.: 2017-1232. Available from http://www.ncbi.nlm.nih.gov/books/NBK453378/

  PMID: 28910066 RESULT

• Sarvazyan A, Egorov V, Son JS, Kaufman CS. Cost-effective screening for breast cancer worldwide: current state and future directions. Breast Cancer (Auckl). 2008;1:91-9. doi: 10.4137/bcbcr.s774. Epub 2008 Jul 2.

  PMID: 19578481 RESULT

Related Links

• SEER 2022
• USPSTF

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Christina Cinelli, MD

  Maine Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jackie LaPointe, CCRC

CONTACT

(207)-396-8675; Bexa-study@mainehealth.org

Kara Jones

CONTACT

kara.jones@mybexa.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 300 women presenting for screening mammograms and 400 women presenting for diagnostic mammography will undergo the Bexa Breast exam (BBE). Bexa examiners will be blinded regarding each subject's origin (screening vs. diagnostic mammogram). Each woman will receive digital breast tomosynthesis and a BBE exam on the same day. All women with a positive finding on either digital breast tomosynthesis or BBE will have an ultrasound examination of all positive findings. Up to six Bexa Certified examiners will rotate, performing the BBE's on roughly equal proportions of the subjects at a location designated within the Breast Center so as to minimally disrupt patient workflow within the site and also provide minimal inconvenience to the trial participant.

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: May 31, 2023
• Study Start: May 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 31, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share