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Evaluation of the Bexa Breast Examination

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
30 Years to 75 Years
Sex
Female only
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Ultrasound, Pills

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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 Bexa™ device, hereafter referred to as "Bexa" consists of a sensor module (similar in shape to a computer mouse) with a capacitive sensor array that is connected to a tablet computer to process and visualize the results."
  • "The Bexa device produces a clear and accurate image of breast masses as small as 4mm (as measured by B-mode ultrasound) and misses between 6 and 11% of masses of all types."
  • "The most common next-step evaluation of a mass identified by Bexa is an ultrasound of the mass."
  • "Simple physiologic cysts and benign solid tumors can be easily identified by a focused or "spot," ultrasound of the detected mass."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares the Bexa Breast Exam with a 3D mammogram to see how well it finds breast lumps, including cancer. The Bexa exam uses a Bexa device and a focused ultrasound, which uses sound waves to check breast tissue. The study is for women ages 30–75 getting a screening mammogram who have never had breast cancer.

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. 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. 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. To demonstrate the proportion of women receiving a BBE that require additional imaging studies. Hypothesis: The purpose of this study is to demonstrate that the Bexa Breast Examination's sensitivity and specificity in identifying abnormal breast masses is comparable to the current accepted standard of care, mammography with tomosynthesis.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are a woman age 30–75.
  • You are getting a screening mammogram, an X-ray exam to check for breast cancer.
  • Women of all races, ethnic groups, and income levels may join.
  • You sign a form agreeing to join before any study tests or procedures.

Who can't join

  • You have a breast finding smaller than 0.5 cm or larger than 3.5 cm, or more than 3 findings in one breast.
  • You can feel a breast lump, or an exam shows an obvious change in your breast's shape or skin.
  • Your breasts are too tender to finish the exams, or you have breast skin scars that the Bexa examiner says would prevent a clear exam.
  • You cannot understand or are not willing to sign the form agreeing to join, or you are younger than 30 or older than 75.
  • You are pregnant.
  • You have had breast cancer in either breast or radiation treatment to a breast.
  • You have had one or both breasts removed by surgery.
  • You have had a biopsy (a tissue sample taken for testing) in the past 30 days or any breast surgery in the past 12 months.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

TX