NCT05965180

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: Male
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

14AUG2024- enrollment was increased to 50 subjects

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DEVICE	Fine Needle Photoacoustic Probe	Fine Needle Photoacoustic Probe guided by the standard biopsy system without tissue core extraction

Timeline

• Start date: 2023-10-16
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2023-07-28
• Last updated: 2025-11-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study