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

January 27, 2017 updated by: Sanjiv Sam Gambhir, Stanford University

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

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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Hand held photoacoustic probe

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Measures of hypoxia in the lesion
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (ANTICIPATED)

September 1, 2015

Study Completion (ANTICIPATED)

March 1, 2016

Study Registration Dates

First Submitted

November 14, 2011

First Submitted That Met QC Criteria

January 30, 2013

First Posted (ESTIMATE)

January 31, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

January 30, 2017

Last Update Submitted That Met QC Criteria

January 27, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRS0018
  • SU-09022011-8372 (OTHER: Stanford University)
  • 21623 (City of Hope Medical Center)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on Photoacoustic Imaging (PAI)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe