Photoacoustic Imaging (PAI) of Suspicious Breast Cancers - A Clinical Feasibility Study

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2013 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01780532
First received: November 14, 2011
Last updated: October 11, 2013
Last verified: October 2013
  Purpose

After locating the suspicious lesion/mass with standard of care mammography and/or ultrasound, a photoacoustic scan will be performed in the breast where the lesion is located. After the PA scan a biopsy will be performed, if clinically indicated (based on the mammogram and ultrasound only).


Condition Intervention
Breast Cancer
Procedure: Photoacoustic Imaging (PAI)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Pilot Photoacoustic Imaging (PAI) of Suspicious Breast Cancers - A Clinical Feasibility Study

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • The lesion visibility on PAI, described using a five-level scale: 1. Not visible 2. Barely visible 3. Fair (or moderately visible) 4. Visible 5. Clearly visible. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measures of hypoxia in the lesion [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: May 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Photo Acoustic Imaging
An exploratory, single armed, pilot study designed to evaluate the feasibility of Photo Acoustic Imaging (PAI) in a clinical setting.
Procedure: Photoacoustic Imaging (PAI)
Standard of Care
Other Name: Hand held photoacoustic probe

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have a breast lesion/mass found at physical examination, mammography or ultrasound (US), that has not been surgically resected
  • Patients may have any of the following characteristics:

    • Taking hormones (e.g., contraceptives, hormone replacement therapy, post-cancer Tamoxifen)
    • Breast implants
    • Previous breast biopsy
    • Previous breast surgery
    • Previous breast cancer
    • High risk of breast cancer (e.g., breast cancer susceptibility gene (BRCA) mutations, other gynecologic cancer)
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Patients who have had primary surgical excision of the suspicious finding
  • Pregnant or lactating women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01780532

Locations
United States, California
Stanford University Cancer Institute Not yet recruiting
Stanford, California, United States, 94305
Contact: Stanford Cancer Clinical Trials Office, MD    650-498-7061    ccto-office@stanford.edu   
Principal Investigator: Sanjiv Gambhir, MD         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Sanjiv Gambhir, MD Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01780532     History of Changes
Other Study ID Numbers: BRS0018, SU-09022011-8372, 21623
Study First Received: November 14, 2011
Last Updated: October 11, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 28, 2014