Photoacoustic Imaging (PAI) of Suspicious Breast Cancers... | NCT01780532

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

NCT01780532

Sponsor

Stanford University

Status

Withdrawn

Last Update Posted

Jan 30, 2017Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Breast Cancer

Interventions

Photoacoustic Imaging (PAI)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
SU-09022011-8372	Other Identifier	Stanford University
21623	Other Identifier	Stanford IRB

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Insufficient resources

Expanded Access Info

Start Date

Sep 2014

Primary Completion Date

Sep 2015Estimated

Completion Date

Mar 2016Estimated

First Submitted Date

Nov 14, 2011

First Submission Date that Met QC Criteria

Jan 30, 2013

First Posted Date

Jan 31, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 27, 2017

Last Update Posted Date

Jan 30, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Photo Acoustic Imaging	Experimental	An exploratory, single armed, pilot study designed to evaluate the feasibility of Photo Acoustic Imaging (PAI) in a clinical setting.	Procedure: Photoacoustic Imaging (PAI)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Photoacoustic Imaging (PAI)	Procedure	Standard of Care	Photo Acoustic Imaging

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Measures of hypoxia in the lesion		6 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Sanjiv Gambhir, MD	Stanford University	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided