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

University of Michigan Rogel Cancer Center

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Device: Fine Needle Photoacoustic Probe

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT05965180

R37CA222829 (U.S. NIH Grant/Contract)

UMCC 2022.015

HUM00217834 (Other Identifier)

Details and patient eligibility

About

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.

Full description

14AUG2024- enrollment was increased to 50 subjects

Enrollment: 50 estimated patients

Sex: Male

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

50 participants in 1 patient group

Biopsy

Description:

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.

Treatment:

Device: Fine Needle Photoacoustic Probe