Interstitial Assessment of Architectural Heterogeneity in Prostate Cancer Using a Fine Needle Photoacoustic Probe

NCT ID: NCT05965180

Last Updated: 2025-11-24

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

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-16

Study Completion Date

2026-10-31

Brief Summary

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In this project, we will integrate the Photoacoustic (PA) technology into a prostate biopsy procedure through a fine needle probe. The needle probe will be in the shape of a biopsy needle and compatible with the needle insertion mechanism in the transrectal ultrasound (TRUS) probe. When inserted into the prostate, the fine needle PA probe will assess the histological information in its surrounding tissue without any tissue extraction. The needle probe has been tested in prostate tissue samples and whole human prostates ex vivo.

Detailed Description

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14AUG2024- enrollment was increased to 50 subjects

Conditions

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Prostate Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Biopsy

Patients will be identified once prostate biopsies have been scheduled. Once enrolled on trial, patients will undergo standard biopsy procedure as per clinical care. During this biopsy, research measurements will be completed using the fine needle photoacoustic probe.

Fine Needle Photoacoustic Probe

Intervention Type DEVICE

Fine Needle Photoacoustic Probe guided by the standard biopsy system without tissue core extraction

Interventions

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Fine Needle Photoacoustic Probe

Fine Needle Photoacoustic Probe guided by the standard biopsy system without tissue core extraction

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 1\) Planned prostate biopsy as part of routine clinical care
* 2\) \> 40 and \<80 years old

Exclusion Criteria

* 1\) Known history of bleeding disorders or
* 2\) Patients taking anticoagulants, no matter doses or washout time
* 3\) Known allergy to silicone material
* 4\) Unable to provide informed consent
* 5\) Either the surgeon or the patient do not think the patient will not be able to complete all parts of the study, the patient will be excluded
* 6\) Involved in other investigational studies.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guan Xu, Phd

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Cancer AnswerLine

Role: CONTACT

1-800-865-1125

Facility Contacts

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Cancer AnswerLine

Role: primary

800-865-1125

Other Identifiers

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HUM00217834

Identifier Type: OTHER

Identifier Source: secondary_id

R37CA222829

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UMCC 2022.015

Identifier Type: -

Identifier Source: org_study_id

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