Interstitial Assessment of Architectural Heterogeneity in Prostate Cancer Using a Fine Needle Photoacoustic Probe
Status
RECRUITING
Phase
Age
40 - 80 Years
Enrollments
20Conditions
Prostate CancerSummary
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.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Cancer AnswerLine
- 800-865-1125
- [email protected]
Principal Investigator
- Guan Xu, Phd
Eligibility Criteria
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.
Study Plan
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.
DEVICE:
Fine Needle Photoacoustic ProbeDescription:
Fine Needle Photoacoustic Probe guided by the standard biopsy system without tissue core extraction
Outcome Measures
Primary Outcome Measures
Demonstration of reliable measurements
Secondary Outcome Measures
Determining the ability to observe differences between benign and cancerous regions
Timeline
Last Updated
October 31, 2024Start Date
July 28, 2023Today
May 12, 2025Completion Date ( Estimated )
October 1, 2025
Sponsors of this trial
Lead Sponsor
University of Michigan Rogel Cancer CenterCollaborating Sponsors
National Cancer Institute (NCI)
RECRUITING 
≥ 18 Years