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Trial Title:
Interstitial Assessment of Architectural Heterogeneity in Prostate Cancer Using a Fine Needle Photoacoustic Probe
NCT ID:
NCT05965180
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
Biopsy
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Device
Intervention name:
Fine Needle Photoacoustic Probe
Description:
Fine Needle Photoacoustic Probe guided by the standard biopsy system without tissue core
extraction
Arm group label:
Biopsy
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.
Criteria for eligibility:
Study pop:
Patients with planned prostate biopsy procedures will be recruited through U-M Urology
Clinics
Sampling method:
Non-Probability Sample
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.
Gender:
Male
Minimum age:
40 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Michigan Rogel Cancer Center
Address:
City:
Ann Arbor
Zip:
48109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Cancer AnswerLine
Phone:
800-865-1125
Email:
CancerAnswerLine@med.umich.edu
Investigator:
Last name:
Guan Xu, Phd
Email:
Principal Investigator
Start date:
October 16, 2023
Completion date:
October 2025
Lead sponsor:
Agency:
University of Michigan Rogel Cancer Center
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
University of Michigan Rogel Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05965180
