NCT01780532

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).

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2014

Shorter than P25 for not_applicable breast-cancer

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2011

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

January 31, 2013

Completed
1.6 years until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

January 30, 2017

Status Verified

January 1, 2017

Enrollment Period

1 year

First QC Date

November 14, 2011

Last Update Submit

January 27, 2017

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Secondary Outcomes (1)

  • Measures of hypoxia in the lesion

    6 months

Study Arms (1)

Photo Acoustic Imaging

EXPERIMENTAL

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

Procedure: Photoacoustic Imaging (PAI)

Interventions

Photoacoustic Imaging (PAI)PROCEDURE

Standard of Care

Also known as: Hand held photoacoustic probe
Photo Acoustic Imaging

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients who have had primary surgical excision of the suspicious finding
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Sanjiv Gambhir, MD

    Stanford University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair, Dept. of Radiology

Study Record Dates

First Submitted

November 14, 2011

First Posted

January 31, 2013

Study Start

September 1, 2014

Primary Completion

September 1, 2015

Study Completion

March 1, 2016

Last Updated

January 30, 2017

Record last verified: 2017-01