Transrectal Photoacoustic Imaging of the Prostate | NCT02365883

Studies
Transrectal Photoacoustic Imaging of the Prostate

NCT02365883

Sponsor

Stanford University

Status

Terminated

Last Update Posted

Jun 14, 2022Actual

Enrollment

22Actual

Phase

Not provided

Conditions

Prostate Cancer

Interventions

Photoacoustic Imaging System

Countries

United States

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

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
PROS0044	Other Identifier	OnCore

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

PI passed away

Expanded Access Info

Start Date

Sep 2011Actual

Primary Completion Date

Dec 16, 2016Actual

Completion Date

Jun 3, 2019Actual

First Submitted Date

Feb 11, 2015

First Submission Date that Met QC Criteria

Feb 11, 2015

First Posted Date

Feb 19, 2015Estimated

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

Jun 10, 2022

Last Update Posted Date

Jun 14, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

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

The purpose of this study is to image human prostate tissue using a new transrectal photoacoustic imaging probe and correlate this with ultrasound and MRI imaging performed once the specimen has been surgically removed. We hope to see what we can visualize with our device as this has never been done before. Eventually, we hope to use a similar device to image the prostate in men being seen by their doctor for prostate cancer.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Prostate Cancer Group			Device: Photoacoustic Imaging System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Photoacoustic Imaging System	Device	manufactured by Endra	Prostate Cancer Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quality of images obtained	Pilot study to better understand the quality of both ultrasound and photo acoustic images that can be obtained using a transrectal instrument. To understand acquisition parameters that help optimize the image quality.	18 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed with clinically-localized prostate cancer
Participant desires prostatectomy
Male
Patient receiving treatment at Palo Alto Veterans Administration (VA) Hospital
Age 18 to 80 years old
English-speaking

Exclusion Criteria:

Cannot tolerate a surgical prostatectomy due to medical comorbidities
Cannot give informed consent

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

In order to need a prostatectomy, patient must be male.

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

English-speaking men at the Palo Alto Veterans Hospital between the ages of 18 and 80 years with clinically localized prostate cancer who desire prostatectomy.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sanjiv S. Gambhir	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University Cancer Institute		Stanford	California	94305	United States

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
ICF	No	No	Yes	Informed Consent Form	Jul 31, 2018	Jun 17, 2019	ICF_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided