search
Back to results

Prostate Delineation: High Quality Volume CT

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
High Quality Volume CT Scan; MRI Scan
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring Prostate Cancer, MRI scan, External beam radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. At least 18 years old
  2. Subjects undergoing radical external beam radiotherapy for prostate cancer
  3. Ability to provide written informed consent

Exclusion Criteria:

  1. Age ≤ 18 years
  2. Subjects not suitable for MRI scanning
  3. 3 usable image sets not obtained during treatment planning scans.

Sites / Locations

  • University Health Network, The Princess Margaret

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

High Quality Volume CT Scan; MRI Scan

Arm Description

Patients will have the High Quality volume CT scan immediately after their CT scan followed by MRI Scan.

Outcomes

Primary Outcome Measures

Using different scanning methods for patients undergoing radical external beam radiotherapy for prostate cancer to determine inter-observer variability in prostate gland delineation on the images.

Secondary Outcome Measures

Determine the concordance between delineators in identifying the prostate apex on the 2 CT image sets. MRI will be considered the "gold-standard" for identifying the prostate apex.

Full Information

First Posted
October 24, 2012
Last Updated
August 18, 2017
Sponsor
University Health Network, Toronto
Collaborators
Princess Margaret Hospital, Canada
search

1. Study Identification

Unique Protocol Identification Number
NCT01878773
Brief Title
Prostate Delineation: High Quality Volume CT
Official Title
Prostate Delineation During Radiation Treatment Planning for Prostate Cancer: Comparison of High Quality Volume Computerized Tomography With Conventional Tomography and Magnetic Resonance Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
August 11, 2017 (Actual)
Study Completion Date
August 11, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
Princess Margaret Hospital, Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will look at how feasible it is to use a certain type of Computed Tomography (CT) to scan prostate cancer, called a high quality volume CT scan. It is hoped that this technique will help doctors provide a higher-quality image of the prostate cancer, making it easier to plan the area that will be treated. Using this type of CT scan will also lessen the amount of time patients spend in the scanner. This study will not offer patients a different treatment for their prostate cancer. Patients will receive the most appropriate standard treatment whether or not they are in this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, MRI scan, External beam radiotherapy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Quality Volume CT Scan; MRI Scan
Arm Type
Other
Arm Description
Patients will have the High Quality volume CT scan immediately after their CT scan followed by MRI Scan.
Intervention Type
Other
Intervention Name(s)
High Quality Volume CT Scan; MRI Scan
Intervention Description
Patients will have the High Quality volume CT scan immediately after their CT scan followed by MRI scan. --------------------------------------------------------------------------------
Primary Outcome Measure Information:
Title
Using different scanning methods for patients undergoing radical external beam radiotherapy for prostate cancer to determine inter-observer variability in prostate gland delineation on the images.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Determine the concordance between delineators in identifying the prostate apex on the 2 CT image sets. MRI will be considered the "gold-standard" for identifying the prostate apex.
Time Frame
6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least 18 years old Subjects undergoing radical external beam radiotherapy for prostate cancer Ability to provide written informed consent Exclusion Criteria: Age ≤ 18 years Subjects not suitable for MRI scanning 3 usable image sets not obtained during treatment planning scans.
Facility Information:
Facility Name
University Health Network, The Princess Margaret
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Prostate Delineation: High Quality Volume CT

We'll reach out to this number within 24 hrs