Evaluation of the Bexa Breast Examination

NCT06643767 | Recruiting DMC FDA Device

• 1 other identifier: Pro00080990
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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 to identify and further evaluate abnormal breast masses including cancer. Commercially, this combination of Bexa plus focused ultrasound is called "Bexa Breast ExamTM," and abbreviated as, "BBE." This study compares the Bexa Breast Exam (BBE) to the standard of care (digital breast tomosynthesis) in detecting masses and as a breast cancer early detection examination. The specific objectives are:

1. 1.To measure the sensitivity and specificity of BBE as compared to digital breast tomosynthesis in the general population of women over 30 without a history of breast cancer.
2. 2.To measure the sensitivity and specificity of BBE as compared to digital breast tomosynthesis identifying breast masses including cancer in women with dense breasts.
3. 3.To demonstrate the proportion of women receiving a BBE that require additional imaging studies.

Conditions

Breast Cancer

Keywords

Breast Cancer; Bexa; Breast Cancer Screening; Breast Mass Detection; Breast Imaging

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)

Participants

EXPERIMENTAL

Participants scheduled for screening mammography.

Device: Bexa and focus ultrasound

Interventions

Bexa and focus ultrasound DEVICE

The Bexa exam uses pressure elastography to produce a map of the breast tissue's elasticity to identify any masses. Focused ultrasound is then used to further classify the mass into a BIRADS category.

Also known as: Bexa Breast Exam

Participants

Eligibility Criteria

• Age: 30 Years - 75 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women who present to receive a screening mammogram.
• Women of all races, ethnicities, and socio-economic backgrounds.
• Signed informed consent obtained prior to any study assessments and procedures.
• Age 30-75 years of age and female.

You may not qualify if:

• Women with findings that are \< 0.5 cm or \> 3.5 cm
• Palpable lesion (to the participant)
• Positive clinical 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. Mammograms exert substantially more pressure on the breast.)
• 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 \> 75 years of age.
• Pregnant women.
• Women who have had a mastectomy - unilateral or bilateral.
• Women who have had a recent (past 30 days) biopsy performed.
• Women who have had a prior history of breast cancer in either breast.
• Women who have had radiation to the breast.
• Women who have had any breast surgery within the last 12 months.

Sponsors & Collaborators

• Sure, Inc.: lead
• Hendrick Medical Center: collaborator

Study Sites (1)

Hendrick Health - Vera West Women's Center

Abilene, Texas, 79601, United States

RECRUITING

Related Publications (2)

• 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 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 BACKGROUND

Related Links

• US Preventive Services
• SEER

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• John Cole, DO

  Hendrick Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Danielle Goss, MPH, MHA, CHRC, HEC-C

CONTACT

325-670-2918; dgoss@hendrickhealth.org

Johanna Garzon, MHA

CONTACT

325-670-4464; jgarzoncastro@hendrickhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Open label study; no masking
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: At least 444 women presenting for screening mammograms will undergo the Bexa Breast Exam (BBE). Each woman will receive digital breast tomosynthesis and a BBE on the same day. All women with a positive finding on either digital breast tomosynthesis (mamo-positive), BBE (bexa-positive), or both modalities will undergo a diagnostic ultrasound examination and/or diagnostic mammography of all positive findings.

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: October 16, 2024
• Study Start: October 16, 2024
• Primary Completion: February 28, 2025
• Study Completion: May 31, 2025
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)