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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01780532
• Other study ID #: BRS0018
• Secondary ID: SU-09022011-8372
• Status: Withdrawn
• Phase: N/A
• First received: November 14, 2011
• Last updated: January 27, 2017
• Start date: September 2014
• Est. completion date: March 2016

Study information

• Verified date: January 2017
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• Photoacoustic Imaging (PAI)
Standard of Care

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Measures of hypoxia in the lesion		6 months