Photoacoustic Imaging of the Breast in Patients With Breast Cancer and Healthy Subjects

Photoacoustic Imaging of Human Breast

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03897270

Enrollment

400

Registered

2019-04-01

Start date

2018-10-25

Completion date

2026-02-25

Last updated

2025-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Carcinoma, Healthy Subject

Brief summary

This trial studies photoacoustic imaging of the breast in patients with breast cancer and healthy subjects. Dense breasts typically reduce the sensitivity of a mammography and also is associated with a higher risk of breast cancer. Photoacoustic tomography combines light and sound to provide more information about breast tissue.

Detailed description

PRIMARY OBJECTIVES: I. To identify photoacoustic features of breast malignancy and treatment response OUTLINE: Participants undergo photoacoustic imaging of the breast over 30 minutes. At subject's discretion, imaging may repeat for a total of 10 studies, each in a separate day.

Interventions

PROCEDUREPhotoacoustic Imaging

Undergo photoacoustic imaging of the breast

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Women with clinically suspicious or confirmed breast cancer masses (that have not been surgically removed) and will/have already undergo/undergone breast magnetic resonance imaging (MRI).

Exclusion criteria

* Pregnant women (there are no known risks to these procedures, but any unforeseen risks are as yet undetermined, so pregnant women will be excluded by means of a verbal confirmation at time of screening). * Women who have had breast implants in the previous 6 months. * Women who have had lumpectomy * Adults unable to consent. * Individuals who are not yet adults (infants, children, teenagers). * Pregnant women. * Prisoners. * There is no direct benefit of the study to any subject either non-English or English speaker. To facilitate the consent process, we will exclude non-English speaking subjects.

Design outcomes

Primary

Measure	Time frame	Description
Identify photoacoustic features of breast malignancies	Up to 3 years	Photoacoustic excitation and detection will be performed

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026