RECRUITING

Evaluation of the Bexa Breast Examination

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Conditions

Breast CancerBexaBreast Cancer ScreeningBreast Mass DetectionBreast Imaging

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-10-16
Study Completion:2025-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06643767

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Years to 75 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Women who present to receive a screening mammogram.
  2. 2. Women of all races, ethnicities, and socio-economic backgrounds.
  3. 3. Signed informed consent obtained prior to any study assessments and procedures.
  4. 4. Age 30-75 years of age and female.
  1. 1. Women with findings that are \< 0.5 cm or \> 3.5 cm
  2. 2. Palpable lesion (to the participant)
  3. 3. Positive clinical findings that cause a visible and obvious deformity of the breast or alteration in the skin appearance of the breast.
  4. 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. 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. 6. Greater than 3 positive findings in a given breast.
  7. 7. Women who are unable to comprehend or unwilling to sign an informed consent form.
  8. 8. Women ages \< 30 and \> 75 years of age.
  9. 9. Pregnant women.
  10. 10. Women who have had a mastectomy - unilateral or bilateral.
  11. 11. Women who have had a recent (past 30 days) biopsy performed.
  12. 12. Women who have had a prior history of breast cancer in either breast.
  13. 13. Women who have had radiation to the breast.
  14. 14. Women who have had any breast surgery within the last 12 months.

Contacts and Locations

Study Contact

Danielle Goss, MPH, MHA, CHRC, HEC-C
CONTACT
325-670-2918
dgoss@hendrickhealth.org
Johanna Garzon, MHA
CONTACT
325-670-4464
jgarzoncastro@hendrickhealth.org

Principal Investigator

John Cole, DO
PRINCIPAL_INVESTIGATOR
Hendrick Health

Study Locations (Sites)

Hendrick Health - Vera West Women's Center
Abilene, Texas, 79601
United States

Collaborators and Investigators

Sponsor: Sure, Inc.

  • John Cole, DO, PRINCIPAL_INVESTIGATOR, Hendrick Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-16
Study Completion Date2025-05-31

Study Record Updates

Study Start Date2024-10-16
Study Completion Date2025-05-31

Terms related to this study

Keywords Provided by Researchers

  • Breast Cancer
  • Bexa
  • Breast Cancer Screening
  • Breast Mass Detection
  • Breast Imaging

Additional Relevant MeSH Terms

  • Breast Cancer