Recruiting

Photoacoustic Imaging

Sponsor:

Roswell Park Cancer Institute

Code:

NCT03897270

Conditions

Breast Carcinoma

Healthy Subject

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Photoacoustic Imaging

Study Details

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

Study ID

NCT03897270

Start date

Oct 25, 2018

Status verified date

Apr, 2026

Completion date

Aug 25, 2026

Anticipated

Primary completion date

Aug 25, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

400 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Diagnostic (photoacoustic imaging of the breast)

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

Photoacoustic Imaging

Undergo photoacoustic imaging of the breast

Primary outcome measure

  • Identify photoacoustic features of breast malignancies [ Time Frame: Up to 3 years ]

Central Contacts and Locations

Locations

Roswell Park Cancer Institute

Recruiting

Buffalo, New York, United States, 14263

Contacts

Ermelinda Bonaccio

800-765-9355AskRoswelI@roswellpark.org

Principal Investigator:

Ermelinda Bonaccio

More Information

Sponsor

Roswell Park Cancer Institute

Last update posted

Apr 7, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Roswell Park Cancer Institute on 2026-04-07.