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

Primary Purpose

Breast Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Photoacoustic Imaging (PAI)
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Photo Acoustic Imaging

    Arm Description

    An exploratory, single armed, pilot study designed to evaluate the feasibility of Photo Acoustic Imaging (PAI) in a clinical setting.

    Outcomes

    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.

    Secondary Outcome Measures

    Measures of hypoxia in the lesion

    Full Information

    First Posted
    November 14, 2011
    Last Updated
    January 27, 2017
    Sponsor
    Stanford University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01780532
    Brief Title
    Photoacoustic Imaging (PAI) of Suspicious Breast Cancers - A Clinical Feasibility Study
    Official Title
    Pilot Photoacoustic Imaging (PAI) of Suspicious Breast Cancers - A Clinical Feasibility Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Insufficient resources
    Study Start Date
    September 2014 (undefined)
    Primary Completion Date
    September 2015 (Anticipated)
    Study Completion Date
    March 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Stanford University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Photo Acoustic Imaging
    Arm Type
    Experimental
    Arm Description
    An exploratory, single armed, pilot study designed to evaluate the feasibility of Photo Acoustic Imaging (PAI) in a clinical setting.
    Intervention Type
    Procedure
    Intervention Name(s)
    Photoacoustic Imaging (PAI)
    Other Intervention Name(s)
    Hand held photoacoustic probe
    Intervention Description
    Standard of Care
    Primary Outcome Measure Information:
    Title
    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
    Secondary Outcome Measure Information:
    Title
    Measures of hypoxia in the lesion
    Time Frame
    6 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sanjiv Gambhir, MD
    Organizational Affiliation
    Stanford University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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