Comparing two ultrasound technologies for breast cancer survivors
Feasibility of Automated Breast Ultrasound (ABUS) Versus Handheld Ultrasound (HHUS) for Breast Cancer Surveillance in Women With Nipple Sparing or Skin Sparing Mastectomy With Reconstruction
NA · Thomas Jefferson University · NCT05408260
This study is testing whether a new automated breast ultrasound can find leftover tissue better than a handheld ultrasound in women who have had breast reconstruction after cancer.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Thomas Jefferson University (other) |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT05408260 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of automated breast ultrasound (ABUS) versus handheld ultrasound (HHUS) in screening women who have undergone breast reconstruction after breast cancer. The primary objective is to demonstrate that ABUS reduces artifacts compared to HHUS in detecting residual tissue in patients who have had nipple-sparing or skin-sparing mastectomies. Secondary objectives include assessing the performance and interpretation times of both ultrasound methods, as well as patient comfort and interest in future screenings. Participants will undergo both ultrasound types, and those with suspicious results will be referred for biopsy.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older who have had unilateral nipple-sparing or skin-sparing mastectomy with reconstruction and are free of focal breast symptoms.
Not a fit: Patients with a history of breast cancer recurrence or current focal breast symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve screening accuracy for breast cancer survivors, leading to better detection of potential issues in reconstructed breasts.
How similar studies have performed: While ABUS has shown promise in whole breast screening, this specific application for reconstructed patients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female * \>= 18 years of age at time of consent * Free of focal breast symptoms and with no suspicious breast physical exam findings * Previous unilateral NSM or SSM with implant (silicone, saline) or flap reconstruction performed at Thomas Jefferson University Hospital * Must be able to understand and provide signed and dated informed consent form. If a patient understands the informed consent but is unable to sign, a legally authorized representative (LAR) may sign * Willing to comply with all study procedures and be available for the duration of the study * Willing to honor any bills that may be incurred if the insurance company does not pay for the billed bilateral hand held ultrasound Exclusion Criteria: * History of breast cancer recurrence * Current focal breast symptoms since NSM or SSM with reconstruction * NSM or SSM with reconstruction was performed years prior to study enrollment * Bilateral NSM or SSM with reconstruction * Females who are pregnant
Where this trial is running
Philadelphia, Pennsylvania
- Sidney Kimmel Cancer Center at Thomas Jefferson University — Philadelphia, Pennsylvania, United States (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Malignant Breast Neoplasm