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

Not Applicable

Recruiting

• Conditions: Breast Carcinoma; Healthy Subject
• Interventions: Procedure: Photoacoustic Imaging

• Registration Number: NCT03897270
• Lead Sponsor: Roswell Park Cancer Institute

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.

Study Timeline

• Study Start: 2018-10-25
• Study First Submitted: 2019-03-22
• Study First Submitted QC: 2019-03-28
• Study First Posted: 2019-04-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-10
• Primary Completion: 2025-06-25
• Study Completion: 2025-06-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 400

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (photoacoustic imaging of the breast)	Photoacoustic Imaging	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.

Primary Outcome Measures

Name	Time	Method
Identify photoacoustic features of breast malignancies	Up to 3 years	Photoacoustic excitation and detection will be performed

Trial Locations

Locations (1)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States