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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05965180
• Other study ID #: UMCC 2022.015
• Secondary ID: HUM00217834R37CA
• Status: Recruiting
• Start date: October 16, 2023
• Est. completion date: October 2025

Study information

• Verified date: October 2023
• Source: University of Michigan Rogel Cancer Center
• Contact: Cancer AnswerLine
• Phone: 1-800-865-1125
• Email: CancerAnswerLine[@]med.umich.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• Fine Needle Photoacoustic Probe
Fine Needle Photoacoustic Probe guided by the standard biopsy system without tissue core extraction

Locations

Country	Name	City	State
United States	University of Michigan Rogel Cancer Center	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan Rogel Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demonstration of reliable measurements	The primary aim of this study is to demonstrate that our fine needle PA probe can acquire reliable measurements of prostate glands. This will be indicated by a signal-to-noise ratio of the measurements that is larger than one.; We will calculate the signal to noise ratio of the signals as the peak-to-peak signal magnitude over the amplitude of the system background signal. The technical failure is that we will not be able to achieve measurements with signal-to-noise ratios larger than 1 in 10% of the measurements. We will have a futility analysis after first 5 patients are completed (thus 10 measurements). If of those 10 measurements, 2 have a SNR less 1, then the study will be stopped as it is unlikely to meet its 90% target.	day 1
Secondary	Determining the ability to observe differences between benign and cancerous regions	The secondary aim of this study is documenting our ability to observe differences between the PASA linear slope values derived from benign and cancerous regions, i.e., to detect the difference of 0.05 of 0.19, 0.17, 0.14, 0.20 dB/MHz between the means of the linear slopes in benign and cancerous regions at the wavelengths of 1220 nm, 1370 nm, 800 nm and 266 nm, respectively.; We will aim at differentiating the measurements in benign and cancerous regions at specific wavelengths. We have a null hypothesis for each wavelength that at this specific wavelength, our measurement cannot differentiate the benign and cancerous regions. We will test the hypothesis with paired t-tests.	day 1