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New ultrasound technique could spot breast cancer without a needle

NCT ID NCT06878547

Diagnosis Sponsor: UNC Lineberger Comprehensive Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a new, non-invasive ultrasound method to see if it can tell the difference between benign and malignant breast tumors. Researchers will also check if it can measure how well breast cancer responds to chemotherapy. Up to 250 women with breast lumps or breast cancer will take part. The goal is to improve breast cancer diagnosis and treatment monitoring without the need for biopsies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Potential study participants will be patients 20-90 years of age. In the first study arm, patients with suspicious breast lesions that are rated 4 (suspicious)or 5 (highly suggestive of malignancy) on the BI-RADS scale will be recruited. In the second study arm, patients with confirmed malignant breast lesion (s) (BI-RADS 6) who are to undergo neoadjuvant systemic therapy will be recruited. All patients will be recruited from and imaged at the University of North Carolina Hospitals. Based on local demographics, we estimate that roughly 20% will be racial and ethnic minorities. Children will not be included in this study. There will be no randomization to study arms and no intervention beyond ARFI, VisR, and DDAI ultrasound imaging.

Ages

20 to 90 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria (Arm 1): * Subjects are 20-90 years of age * Subjects are female * Breast lesion is sonographically visible with B-Mode ultrasound on diagnostic workup * Breast lesion(s) have BI-RADS 4a, 4b, 4c, or 5 rating Exclusion Criteria (Arm 1): * Inability to provide informed consent * Inability to communicate in English * Inability to remain motionless for 15 minutes * Subjects with breast implants * Breast mass is deeper than 4 cm from skin surface * Subjects who are pregnant or lactating * Subjects who have pacemakers or implanted cardioverters * Subjects with a history of mastectomy * Previous biopsy or surgery to the site of the mass, surgical excision of mass of interest * Subject is male Inclusion Criteria (Arm 2): * Subjects are 20-90 years of age * Subjects are female * Breast lesion is sonographically visible with B-Mode ultrasound on diagnostic workup * Breast lesion(s) have BI-RADS 6 rating, subject will be undergoing NAT for stage 2 or 3 malignant breast lesion(s) Exclusion Criteria (Arm 2): * Inability to provide informed consent * Inability to communicate in English * Inability to remain motionless for 15 minutes * Subjects with breast implants * Breast mass is deeper than 4 cm from skin surface * Subjects who are pregnant or lactating * Subjects who have pacemakers or implanted cardioverters * Subjects with a history of mastectomy * Previous biopsy or surgery to the site of the mass, surgical excision of mass of interest * Subject is male

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Conditions

The condition(s) this trial relates to.

breast benign neoplasm breast cancer breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of North Carolina at Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27514, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.