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

Primary Purpose

Malignant Breast Neoplasm

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultrasonography
Automated Breast Ultrasound
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Malignant Breast Neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Sidney Kimmel Cancer Center at Thomas Jefferson UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Screening (automated breast ultrasound, handheld ultrasound)

Arm Description

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

Outcomes

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)
This is a binary endpoint. The rate of artifact will be compared between handheld and automated scanning using McNemar test.

Secondary Outcome Measures

Full Information

First Posted
June 2, 2022
Last Updated
June 2, 2023
Sponsor
Thomas Jefferson University
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1. Study Identification

Unique Protocol Identification Number
NCT05408260
Brief Title
A Study to Compare the Effectiveness of Two Types of Ultrasound Technologies in Women Who Have Had Breast Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 18, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Breast Neoplasm

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Screening (automated breast ultrasound, handheld ultrasound)
Arm Type
Experimental
Arm Description
Participants undergo HHUS and ABUS in no required order over 1 hour.
Intervention Type
Procedure
Intervention Name(s)
Ultrasonography
Intervention Description
Undergo HHUS
Intervention Type
Procedure
Intervention Name(s)
Automated Breast Ultrasound
Other Intervention Name(s)
ABUS
Intervention Description
Undergo ABUS
Primary Outcome Measure Information:
Title
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)
Description
This is a binary endpoint. The rate of artifact will be compared between handheld and automated scanning using McNemar test.
Time Frame
Up to 1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Sidney Kimmel Cancer Center at Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Zorn, MD
Phone
215-955-2811
Email
Lisa.Zorn@jefferson.edu

12. IPD Sharing Statement

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

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