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New treatment option for Breast Cancer
Official title Evaluation of the Bexa Breast Examination
ClinicalTrials.gov ID: NCT06643767
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 75, women only. Healthy volunteers may be eligible.
You may be able to join 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 likely can't join if
- Women with findings that are \ 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...
- Women with breast significant skin scarring enough to prevent effective BBE (e.g., keloid scarring of the breast, for example), because extensive...
- Greater than 3 positive findings in a given breast.
See the full eligibility criteria
- 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.
- Women with findings that are \ 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...
- 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...
- 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 \ 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.
The study team makes the final eligibility decision.
Where it's taking place
- Abilene, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 30 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Abilene, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.