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

NCT ID: NCT01780532

Last Updated: 2017-01-30

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2016-03-31

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).

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Photo Acoustic Imaging

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

Group Type: EXPERIMENTAL

Photoacoustic Imaging (PAI)

Intervention Type: PROCEDURE

Standard of Care

Interventions

Photoacoustic Imaging (PAI)

Standard of Care

Intervention Type: PROCEDURE

Other Intervention Names

Hand held photoacoustic probe

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Sanjiv Sam Gambhir

Chair, Dept. of Radiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sanjiv Gambhir, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Other Identifiers

SU-09022011-8372

Identifier Type: OTHER

Identifier Source: secondary_id

21623

Identifier Type: OTHER

Identifier Source: secondary_id

BRS0018

Identifier Type: -

Identifier Source: org_study_id