Breast Cancer Clinical Trial

A Study to Compare the Effectiveness of Two Types of Ultrasound Technologies in Women Who Have Had Breast Cancer

Summary

This clinical trial evaluates automated breast ultrasound (ABUS) and handheld ultrasound (HHUS) for the screening of women who have undergone breast reconstruction after breast cancer. Ultrasounds use high-frequency sound waves to create pictures of internal organs and tissues. ABUS has been found to be equal to HHUS for whole breast screening, but no data exist on its use for screening of reconstructed patients. This clinical trial evaluates the feasibility of using ABUS versus HHUS to screen women who have undergone reconstruction.

View Full Description

Full Description

PRIMARY OBJECTIVE:

I. To show that ABUS reduces artifact compared to HHUS in terms of detection of the residual tissue in reconstructed nipple sparing mastectomy (NSM) and skin sparing mastectomy (SSM) patients.

View Eligibility Criteria

Eligibility 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 within the last five years
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 > 5 years prior to study enrollment
Bilateral NSM or SSM with reconstruction
Females who are pregnant

Study is for people with:

Breast Cancer

Estimated Enrollment:

30

Study ID:

NCT05408260

Recruitment Status:

Not yet recruiting

Sponsor:

Thomas Jefferson University

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia Pennsylvania, 19107, United States More Info
Lisa Zorn, MD
Contact
215-955-2811
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

30

Study ID:

NCT05408260

Recruitment Status:

Not yet recruiting

Sponsor:


Thomas Jefferson University

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider