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NCT Number: NCT03897270

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

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.

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Key information

Conditions

Breast Carcinoma Breast Diseases Breast Neoplasms Healthy Subject Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location status: Recruiting

Location contact

Ermelinda Bonaccio

CONTACT

[email protected]

800-765-9355

Ermelinda Bonaccio

PRINCIPAL_INVESTIGATOR

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Photoacoustic Imaging

Procedure

Undergo photoacoustic imaging of the breast

Primary outcomes

  1. Identify photoacoustic features of breast malignancies

    Time frame: Up to 3 years

    Photoacoustic excitation and detection will be performed

Sponsors and collaborators

Lead sponsor

Roswell Park Cancer Institute

Other

Collaborators

  • Susan G. Komen Breast Cancer Foundation

Registry information

Official study title

Photoacoustic Imaging of Human Breast

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Apr 1, 2019
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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