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

NCT03897270 | Recruiting

• 2 other identifiers: I 60217NCI-2019-01356
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Carcinoma; Healthy Subject

Outcome Measures

Primary Outcomes (1)

• Identify photoacoustic features of breast malignancies

  Photoacoustic excitation and detection will be performed

  Up to 3 years

Study Arms (1)

Diagnostic (photoacoustic imaging of the breast)

EXPERIMENTAL

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.

Procedure: Photoacoustic Imaging

Interventions

Photoacoustic Imaging PROCEDURE

Undergo photoacoustic imaging of the breast

Diagnostic (photoacoustic imaging of the breast)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• Susan G. Komen Breast Cancer Foundation: collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ermelinda Bonaccio

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2019
• First Posted: April 1, 2019
• Study Start: October 25, 2018
• Primary Completion: February 25, 2026
• Study Completion: February 25, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-12

Locations

US (1)