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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Screening (automated breast ultrasound, handheld ultrasound)Experimental Treatment2 Interventions

Participants undergo HHUS and ABUS in no required order over 1 hour.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ultrasonography

2013

Completed Phase 4

~4320

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Thomas Jefferson UniversityLead Sponsor

445 Previous Clinical Trials

145,459 Total Patients Enrolled

5 Trials studying Breast Cancer

607 Patients Enrolled for Breast Cancer

Media Library

Automated Breast Ultrasound Clinical Trial Eligibility Overview. Trial Name: NCT05408260 — N/A

Breast Cancer Research Study Groups: Screening (automated breast ultrasound, handheld ultrasound)

Breast Cancer Clinical Trial 2023: Automated Breast Ultrasound Highlights & Side Effects. Trial Name: NCT05408260 — N/A

Automated Breast Ultrasound 2023 Treatment Timeline for Medical Study. Trial Name: NCT05408260 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the present enrollment number for this research project?

"Affirmative. Per information hosted on clinicaltrials.gov, this investigation is currently accepting applications from potential participants. This trial was initially published on November 18th 2022 and recently revised on the 21st of that same month. A total of 30 individuals need to be enrolled at one site for the study's completion."

Answered by AI

Are there still open slots for participants in this clinical study?

"Indeed, clinicaltrials.gov indicates that this research is still open for participants. The trial was launched on November 18th 2022 and has seen recent activity on the 21st of the same month. 30 individuals are being sought to join this single-site study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "A Study to Compare the Effectiveness of Two Types of Ultrasound Technologies in Women Who Have Had Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05408260.