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


N/A
18 Years
80 Years
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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.

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Sanjiv Gambhir, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Institutional Review Board

Study ID:

BRS0018

NCT ID:

NCT01780532

Start Date:

May 2013

Completion Date:

November 2014

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

Name

Location

Stanford University Cancer Institute Stanford, California  94305