Interstitial Assessment of Architectural Heterogeneity in Prostate Cancer Using a Fine Needle Photoacoustic Probe
Recruiting · NCT05965180 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Fine Needle Photoacoustic Probe
What this trial is 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.
Who can take part
Age range
40 Years to 80 Years
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
1 location listed across 1 US state.
- University of Michigan Rogel Cancer Center - Ann Arbor, Michigan, United States