CAPTURE: Capture of Prostatic Trans-rectal Ultrasound Scans for Research

Sponsor
Cambridge University Hospitals NHS Foundation Trust (Other)
Overall Status
Suspended
CT.gov ID
NCT03321864
Collaborator
University of Cambridge (Other)
150
1
1
60
2.5

Study Details

Study Description

Brief Summary

Through this study the investigators seek to build up a repository of prostate ultrasonography videos and prostate MRI scans to enable research into novel anatomical registration techniques. These data will facilitate the development of improved technology that enables targeting of tumours seen on MRI using free-hand biopsy techniques, without the need for a gantry or overlaid perineal grid.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Transrectal ultrasound scan of prostate
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
All available patientsAll available patients
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Capture of Prostatic Trans-rectal Ultrasound Scans for Research Into Improved Targeted Biopsy Techniques (CAPTURE)
Actual Study Start Date :
Jan 1, 2018
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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.

Procedure: Transrectal ultrasound scan of prostate
Additional transrectal ultrasound whilst already under GA for transperineal biopsy.

Outcome Measures

Primary Outcome Measures

  1. Prostate size [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.

  2. Prostate location [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Addenbrookes Hospital Cambridge Cambridgeshire United Kingdom CB2 0QQ

Sponsors and Collaborators

  • Cambridge University Hospitals NHS Foundation Trust
  • University of Cambridge

Investigators

  • Principal Investigator: David Thurtle, University of Cambridge

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
David Thurtle, Clinical Research Associate and Honorary Urology Registrar, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT03321864
Other Study ID Numbers:
  • A094516
  • 228575
First Posted:
Oct 26, 2017
Last Update Posted:
Jul 10, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by David Thurtle, Clinical Research Associate and Honorary Urology Registrar, Cambridge University Hospitals NHS Foundation Trust
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 10, 2020