Evaluation of the Bexa Breast Examination for breast cancer detection

Evaluation of the Bexa Breast Examination (BBE) as an Effective Solution to Breast Cancer Early Detection

This study is testing a new breast exam that uses a special device and ultrasound to see if it can find breast cancer better than regular mammograms, especially for women over 30 and those with dense breast tissue.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 500 (estimated)
• Ages: 30 Years to 75 Years
• Sex: Female
• Sponsor: Sure, Inc. (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 1 site (Abilene, Texas)
• Trial ID: NCT06643767 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of the Bexa Breast Exam (BBE), which combines a Bexa device with focused ultrasound, in detecting breast masses compared to standard digital breast tomosynthesis. The trial aims to measure the sensitivity and specificity of BBE in women over 30 without a history of breast cancer, as well as in women with dense breast tissue. By providing immediate results and reducing the discomfort associated with traditional mammography, this approach seeks to improve early detection of breast cancer.

Who should consider this trial

Good fit: Ideal candidates for this study are women aged 30 to 75 who are presenting for a screening mammogram.

Not a fit: Patients with palpable lesions or significant breast tenderness that would prevent them from completing the examinations may not benefit from this study.

Why it matters

Potential benefit: If successful, this method could lead to earlier and more accurate detection of breast cancer, potentially saving lives.

How similar studies have performed: While traditional mammography has been the standard, this novel approach using Bexa and focused ultrasound has not been extensively tested in similar studies.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Women with findings that are \< 0.5 cm or \> 3.5 cm
2. Palpable lesion (to the participant)
3. Positive clinical findings that cause a visible and obvious deformity of the breast or alteration in the skin appearance of the breast.
4. 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.)
5. Women with breast significant skin scarring enough to prevent effective BBE (e.g., keloid scarring of the breast, for example), because extensive, hard surface scarring introduces artifact in the Bexa exam. Participant exclusion will be determined by the Bexa examiner.
6. Greater than 3 positive findings in a given breast.
7. Women who are unable to comprehend or unwilling to sign an informed consent form.
8. Women ages \< 30 and \> 75 years of age.
9. Pregnant women.
10. Women who have had a mastectomy - unilateral or bilateral.
11. Women who have had a recent (past 30 days) biopsy performed.
12. Women who have had a prior history of breast cancer in either breast.
13. Women who have had radiation to the breast.
14. Women who have had any breast surgery within the last 12 months.

Where this trial is running

Abilene, Texas

• Hendrick Health - Vera West Women's Center — Abilene, Texas, United States (Recruiting)

Study contacts

• Principal investigator: John Cole, DO — Hendrick Health
• Study coordinator: Danielle Goss, MPH, MHA, CHRC, HEC-C

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