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

Roswell Park Comprehensive Cancer Center

Status: Enrolling

Conditions: Healthy Subject; Breast Carcinoma

Treatments: Procedure: Photoacoustic Imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT03897270

NCI-2019-01356 (Registry Identifier)

I 60217 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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400 participants in 1 patient group

Diagnostic (photoacoustic imaging of the breast)

Experimental group

Description:

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.

Treatment:

Procedure: Photoacoustic Imaging