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Recruiting

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

NCT03897270 · Roswell Park Cancer Institute
In plain English

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Official title
Photoacoustic Imaging of Human Breast
About this study
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.
Eligibility criteria
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 target: 400 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2018-10-25
Estimated completion: 2026-08-25
Last updated: 2026-04-07
Interventions
Procedure: Photoacoustic Imaging
Primary outcomes
  • Identify photoacoustic features of breast malignancies (Up to 3 years)
Sponsor
Roswell Park Cancer Institute · other
With: Susan G. Komen Breast Cancer Foundation
Contacts & investigators
InvestigatorErmelinda Bonaccio · principal_investigator, Roswell Park Cancer Institute
All locations (1)
Roswell Park Cancer InstituteRecruiting
Buffalo, New York, United States
Photoacoustic Imaging of the Breast in Patients With Breast Cancer and Healthy Subjects · TrialPath