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Ultrasound Technologies for Post-Reconstruction Breast Cancer Screening

N/A

Recruiting

Research Sponsored by Thomas Jefferson University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Previous unilateral NSM or SSM with implant (silicone, saline) or flap reconstruction performed at Thomas Jefferson University Hospital

Female

Must not have

Bilateral NSM or SSM with reconstruction

Current focal breast symptoms since NSM or SSM with reconstruction

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare automated breast ultrasound (ABUS) to handheld ultrasound (HHUS) for screening women who have had breast reconstruction after breast cancer.

Who is the study for?

This trial is for women over 18 who've had breast reconstruction after cancer. They should have no current breast symptoms or history of recurrence, and must not be pregnant. The surgery must have been within the last five years at Thomas Jefferson University Hospital.

What is being tested?

The study compares two ultrasound technologies: Automated Breast Ultrasound (ABUS) and Handheld Ultrasound (HHUS), to see which is better for screening women with reconstructed breasts after breast cancer treatment.

What are the potential side effects?

Ultrasounds are generally safe but may cause discomfort during the procedure. There's a small risk of incorrect results leading to unnecessary follow-up tests or missed abnormalities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had breast surgery with implant or flap reconstruction at Thomas Jefferson University Hospital.

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I am female.

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I am 18 years old or older.

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I have no breast lumps or unusual symptoms.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had both breasts surgically removed with immediate reconstruction.

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I have breast symptoms after nipple-sparing or skin-sparing mastectomy with reconstruction.

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I am currently pregnant.

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My breast cancer has come back after treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Detection of the residual tissue (i.e., artifact) in reconstructed nipple sparing mastectomy (NSM) and skin sparing mastectomy (SSM) patients by automated breast ultrasound (ABUS) and handheld ultrasound (HHUS)