Malignant Breast NeoplasmNCT05408260
A Study to Compare the Effectiveness of Two Types of Ultrasound Technologies in Women Who Have Had Breast Cancer
A study testing Ultrasonography and Automated Breast Ultrasound in people with Malignant Breast Neoplasm, run by Thomas Jefferson University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Malignant Breast Neoplasm
- What is being tested?
- Ultrasonography and Automated Breast Ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2022to 17 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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.
SECONDARY OBJECTIVES:
- To evaluate both the performance and interpretation times for ABUS and HHUS so that these factors can be considered when scheduling patients and for ease of implementation into practice.
II. A short survey will be administered immediately after both ultrasounds performed to enrolled patients to assess their experience with HHUS and ABUS, specifically addressing their perceived comfort level on a numerical scale and if they would be interested in obtaining subsequent annual screening HHUS or ABUS.
EXPLORATORY OBJECTIVE:
- The appearance of native and reconstructed anatomy on ABUS and HHUS will be studied.
OUTLINE:
Participants undergo HHUS and ABUS in no required order over 1 hour.
Participants with ultrasound results indicating Breast Imaging Reporting and Data System (BI-RADS) 4 or 5 (suspicious and needs biopsy) undergo biopsy within 30 days.
- Conditions
- Malignant Breast Neoplasm
- Being tested
- Ultrasonography, Automated Breast Ultrasound
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasonographyProcedure or surgery
Undergo HHUS
Automated Breast UltrasoundProcedure or surgery
Also called ABUS
Undergo ABUS
| Study group | Role | What they receive |
|---|---|---|
| Screening (automated breast ultrasound, handheld ultrasound) | Experimental | Participants undergo HHUS and ABUS in no required order over 1 hour. Receives: Procedure: Ultrasonography; Procedure: Automated Breast Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start18 Nov 2022
- Primary completion17 Feb 2025
- Study completion17 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Breast NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05408260
- Sponsor's protocol ID
- 19D.799
- Other IDs
- JT 14405
- Status last verified
- Dec 2025
- First submitted
- 2 Jun 2022
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05408260
- Acronym / sponsor ID
- 19D.799
- Conditions
- Malignant Breast Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 18 Nov 2022 (actual)
- Primary completion
- 17 Feb 2025 (actual)
- Study completion
- 17 Feb 2025 (actual)
- First posted
- 7 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
SECONDARY OBJECTIVES:
- To evaluate both the performance and interpretation times for ABUS and HHUS so that these factors can be considered when scheduling patients and for ease of implementation into practice.
II. A short survey will be administered immediately after both ultrasounds performed to enrolled patients to assess their experience with HHUS and ABUS, specifically addressing their perceived comfort level on a numerical scale and if they would be interested in obtaining subsequent annual screening HHUS or ABUS.
EXPLORATORY OBJECTIVE:
- The appearance of native and reconstructed anatomy on ABUS and HHUS will be studied.
OUTLINE:
Participants undergo HHUS and ABUS in no required order over 1 hour.
Participants with ultrasound results indicating Breast Imaging Reporting and Data System (BI-RADS) 4 or 5 (suspicious and needs biopsy) undergo biopsy within 30 days.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening (automated breast ultrasound, handheld ultrasound) | Experimental | Procedure: Ultrasonography, Procedure: Automated Breast UltrasoundParticipants undergo HHUS and ABUS in no required order over 1 hour. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasonographyUndergo HHUS | Procedure or surgery | Screening (automated breast ultrasound, handheld ultrasound) |
| Automated Breast UltrasoundAlso: ABUSUndergo ABUS | Procedure or surgery | Screening (automated breast ultrasound, handheld ultrasound) |
Primary outcome
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)
Time frame: Up to 1 year
This is a binary endpoint. The rate of artifact will be compared between handheld and automated scanning using McNemar test.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonography and Automated Breast Ultrasound in people with Malignant Breast Neoplasm, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.