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

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ClinicalTrials.gov Identifier: NCT03897270
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : April 1, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Susan G. Komen Breast Cancer Foundation
Information provided by (Responsible Party):
Roswell Park Cancer Institute

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.

Condition or disease Intervention/treatment Phase
Breast Carcinoma Healthy Subject Procedure: Photoacoustic Imaging Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Photoacoustic Imaging of Human Breast
Actual Study Start Date : October 18, 2018
Estimated Primary Completion Date : May 15, 2021
Estimated Study Completion Date : May 15, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Diagnostic (photoacoustic imaging of the breast)
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.
Procedure: Photoacoustic Imaging
Undergo photoacoustic imaging of the breast




Primary Outcome Measures :
  1. Identify photoacoustic features of breast malignancies [ Time Frame: Up to 3 years ]
    Photoacoustic excitation and detection will be performed



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03897270


Locations
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United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Ermelinda Bonaccio    800-765-9355    AskRoswelI@roswellpark.org   
Principal Investigator: Ermelinda Bonaccio         
Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Susan G. Komen Breast Cancer Foundation
Investigators
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Principal Investigator: Ermelinda Bonaccio Roswell Park Cancer Institute

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Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT03897270     History of Changes
Other Study ID Numbers: I 60217
NCI-2019-01356 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
I 60217 ( Other Identifier: Roswell Park Cancer Institute )
P30CA016056 ( U.S. NIH Grant/Contract )
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019

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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
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases