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

Not Applicable

Withdrawn

• Conditions: Breast Cancer
• Interventions: Procedure: Photoacoustic Imaging (PAI)

• Registration Number: NCT01780532
• Lead Sponsor: Stanford University

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-11-14
• Study First Submitted QC: 2013-01-30
• Study First Posted: 2013-01-31
• Study Start: 2014-09
• Primary Completion: 2015-09
• Study Completion: 2016-03
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-27
• Last Update Posted: 2017-01-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Measures of hypoxia in the lesion	6 months