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

Primary Purpose

Breast Carcinoma, Healthy Subject

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Photoacoustic Imaging
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts 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 or are undergoing neoadjuvant chemotherapy.
  • 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.

Sites / Locations

  • Roswell Park Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (photoacoustic imaging of the breast)

Arm 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.

Outcomes

Primary Outcome Measures

Identify photoacoustic features of breast malignancies
Photoacoustic excitation and detection will be performed

Secondary Outcome Measures

Full Information

First Posted
March 22, 2019
Last Updated
September 22, 2023
Sponsor
Roswell Park Cancer Institute
Collaborators
Susan G. Komen Breast Cancer Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03897270
Brief Title
Photoacoustic Imaging of the Breast in Patients With Breast Cancer and Healthy Subjects
Official Title
Photoacoustic Imaging of Human Breast
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 18, 2018 (Actual)
Primary Completion Date
December 18, 2023 (Anticipated)
Study Completion Date
December 18, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute
Collaborators
Susan G. Komen Breast Cancer Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Carcinoma, Healthy Subject

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (photoacoustic imaging of the breast)
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Photoacoustic Imaging
Intervention Description
Undergo photoacoustic imaging of the breast
Primary Outcome Measure Information:
Title
Identify photoacoustic features of breast malignancies
Description
Photoacoustic excitation and detection will be performed
Time Frame
Up to 3 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ermelinda Bonaccio
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ermelinda Bonaccio
Phone
800-765-9355
Email
AskRoswelI@roswellpark.org
First Name & Middle Initial & Last Name & Degree
Ermelinda Bonaccio

12. IPD Sharing Statement

Learn more about this trial

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

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