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

This study is not yet open for participant recruitment.
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
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 April 16, 2014