Prostate Delineation: High Quality Volume CT

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University Health Network, Toronto
Sponsor:
Collaborator:
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01878773
First received: October 24, 2012
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Prostate Cancer
Other: High Quality Volume CT Scan; MRI Scan

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: October 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
High Quality Volume CT Scan; MRI Scan
Patients will have the High Quality volume CT scan immediately after their CT scan followed by MRI Scan.
Other: High Quality Volume CT Scan; MRI Scan

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

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01878773

Contacts
Contact: Charles Catton, MD 416 946 4501 ext 2121 Charles.Catton@rmp.uhn.on.ca
Contact: Hamideh Alasti, PhD 416 946 4501 ext 5812 Hamideh.Alasti@rmp.uhn.on.ca

Locations
Canada, Ontario
University Health Network, The Princess Margaret Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Charles Catton, MD    416 946 4501 ext 2121    Charles.Catton@rmp.uhn.on.ca   
Contact: Hamideh Alasti, PhD    416 946 4501 ext 5812    hamideh.Alasti@rmp.uhn.on.ca   
Principal Investigator: Charles Catton, MD         
Sponsors and Collaborators
University Health Network, Toronto
Princess Margaret Hospital, Canada
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01878773     History of Changes
Other Study ID Numbers: UHN REB 12-5229-CE
Study First Received: October 24, 2012
Last Updated: June 24, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
Prostate Cancer
MRI scan
External beam radiotherapy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on August 19, 2014