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Photoacoustic Imaging (PAI) of the Prostate: A Clinical Feasibility Study

NCT ID: NCT01551576

Last Updated: 2021-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-28

Study Completion Date

2019-12-16

Brief Summary

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The purpose of our study is to image human prostate tissue using a transrectal photoacoustic imaging probe.

Detailed Description

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PRIMARY OBJECTIVE(S):

The primary objective of this pilot study is to assess PAI-performance in a clinical setting to understand limitations of our current PAI instrumentation and to help improve the next-generation design.

SECONDARY OBJECTIVE(S):

To do preliminary evaluations of oxygen saturation in lesions based on PAI-measurements in order to distinguish malignant from benign prostatic tissue as a basis for future studies.

Conditions

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Prostate Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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photoacoustic imaging (PAI)

Men seen in the urology clinic for elevated PSA and/or abnormal digital rectal exam (DRE) will be offered PAI at the time of transrectal ultrasound guided biopsy, which is standard of care. In addition, patients with a biopsy proven prostate cancer may also be approached for this PAI scan

Hand held transrectal Combined Ultrasound and photoacoustic imaging (PAI) probe

Intervention Type DEVICE

Hand held transrectal Combined Ultrasound and photoacoustic imaging (PAI) probe. PAI is a non-ionizing imaging technique

Interventions

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Hand held transrectal Combined Ultrasound and photoacoustic imaging (PAI) probe

Hand held transrectal Combined Ultrasound and photoacoustic imaging (PAI) probe. PAI is a non-ionizing imaging technique

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Consent signed
* Male \>= 18 and \<= 80 years of age
* Patients must have an elevated PSA And/ Or Abnormal digital rectal exam Or Other indication for prostate biopsy Or Patients with biopsy proven prostate cancer who are scheduled for prostatectomy.

Exclusion Criteria

* History of prostatectomy or other surgical history that would preclude transrectal imaging (i.e. abdominal perineal resection), anal stenosis/stricture disease
* Men with anatomic abnormalities or previous surgical history that make transrectal imaging impossible (for example, men with previous abdominal-perineal bowel resections or anal atresia/stenosis)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrei H Iagaru, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Martin Karl Schneider, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University Cancer Institute

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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SU-03012012-9209

Identifier Type: OTHER

Identifier Source: secondary_id

PROS0046

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-22701

Identifier Type: -

Identifier Source: org_study_id