Interstitial Assessment of Architectural Heterogeneity in Prostate Cancer Using a Fine Needle Photoacoustic Probe
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fine Needle Photoacoustic Probe.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: 40 years — 80 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Device Fine Needle Photoacoustic Probe
Fine Needle Photoacoustic Probe guided by the standard biopsy system without tissue core extraction
Primary outcome measures
- Demonstration of reliable measurements [Time frame: day 1]
Secondary outcome measures (1)
- Determining the ability to observe differences between benign and cancerous regions [Time frame: day 1]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
United States · 1 center
- University of Michigan Rogel Cancer Center — Ann Arbor
Identifiers
NCT: NCT05965180 · UMCC 2022.015 · HUM00217834 · R37CA222829