- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03321864
Capture of Prostatic Trans-rectal Ultrasound Scans for Research (CAPTURE)
Capture of Prostatic Trans-rectal Ultrasound Scans for Research Into Improved Targeted Biopsy Techniques (CAPTURE)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to explore whether mathematical and computational modelling techniques can be used to enable anatomical based real-time image registration for guiding prostate biopsies. This would lead to the ability to perform free-hand trans-perineal biopsy without the need for supporting gantries or a biopsy grid placed over the perineum. This will significantly decrease costs of trans-perineal biopsy, reduce the number of puncture sites through the perineal skin - reducing pain and bleeding - and reduce the procedure time. Alongside locally developed local-anaesthetic transperineal biopsy techniques it will allow targeted biopsy to be taken in the outpatient setting, improving patient convenience, and helping health services to meet growing demands on targeted biopsies.
The investigators aim to create a new method of mapping the prostate using free-hand ultrasound, without any additional physical equipment. This may require collaborations with approved International groups with particular skills in relevant mathematical or engineering techniques.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Cambridgeshire
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Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
- Addenbrookes Hospital
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects undergoing trans-perineal prostate biopsy under general anaesthesia who have had an MRI of their prostate within the preceding 12 months.
- Male.
- Age 18-100.
Exclusion Criteria:
- Those unable to provide informed consent.
- Any medical condition, vital sign or laboratory value that, in the opinion of the investigator or responsible anaesthetist makes any prolongation of general anaesthesia unsafe to the participant.
- Patients unable to have an MRI
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Study arm
All patients recruited to the study (this arm) will have an additional transrectal ultrasound whilst already under GA for TP biopsy.
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Additional transrectal ultrasound whilst already under GA for transperineal biopsy.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prostate size
Time Frame: Years 1-5
|
Ultrasound images and videos of the prostate will be captured to measure the length, width and depth of the prostate on ultrasound.
The measurements will be in millimeters (mm).
This will be taken at a single time-point at the time of general anaesthesia for transperineal biopsy.
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Years 1-5
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Prostate location
Time Frame: Years 1-5
|
Ultrasound images and videos of the prostate will be captured to assess prostate location relative to surrounding structures.
Specifically this will mean measuring the distance from the anal verge to the prostate.
Unit of measurment is millimeters (mm).
This will be taken at a single time-point at the time of general anaesthesia for transperineal biopsy.
|
Years 1-5
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: David Thurtle, University of Cambridge
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A094516
- 228575 (Registry Identifier: IRAS ID)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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