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

Stanford University

Status: Withdrawn

Conditions: Breast Cancer

Treatments: Procedure: Photoacoustic Imaging (PAI)

Study type: Interventional

Funder types: Other

Identifiers

NCT01780532

BRS0018

21623 (Other Identifier)

SU-09022011-8372 (Other Identifier)

Details and patient eligibility

About

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).

Sex: Female

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Photo Acoustic Imaging

Experimental group

Description:

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

Treatment:

Procedure: Photoacoustic Imaging (PAI)