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NCT03897270 Clinical Trial

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

Breast Carcinoma Clinical Trial

Official title:
Photoacoustic Imaging of Human Breast

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03897270
Other study ID # I 60217
Secondary ID NCI-2019-01356I
Status Recruiting
Phase N/A
First received
Last updated
Start date October 25, 2018
Est. completion date May 31, 2025

Study information
Verified date January 2024
Source Roswell Park Cancer Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

PRIMARY OBJECTIVES: I. To identify photoacoustic features of breast malignancy. 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date May 31, 2025
Est. primary completion date May 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Photoacoustic Imaging
Undergo photoacoustic imaging of the breast

Locations
Country Name City State
United States Roswell Park Cancer Institute Buffalo New York

Sponsors (2)
Lead Sponsor Collaborator
Roswell Park Cancer Institute Susan G. Komen Breast Cancer Foundation

Country where clinical trial is conducted

United States, 

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