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Recruiting NCT03897270

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

No phase Interventional Breast Carcinoma Healthy Subject

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Photoacoustic Imaging.
Who it may be relevant to
Registry conditions: Breast Carcinoma, Healthy Subject. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Photoacoustic Imaging of Human Breast

Overview

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.

Detailed 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.

Interventions

  • Procedure Photoacoustic Imaging
    Undergo photoacoustic imaging of the breast

Primary outcome measures

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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • Roswell Park Cancer Institute — Buffalo

Identifiers

NCT: NCT03897270 · I 60217 · NCI-2019-01356 · I 60217

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗