- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01355185
Seed Movement in Prostate Brachytherapy Implants: Clinical Measurement and Dosimetric Consequences
October 1, 2014 updated by: AHS Cancer Control Alberta
There are substantial uncertainties with contemporary seed placement techniques in prostate brachytherapy, particularly with the impact of seed movement after an implant due to edema and migration of seeds in the prostate and peri-prostatic tissues.
This study will accrue 20 patients undergoing prostate brachytherapy implants and perform serial CT and MRI scans at specified intervals (pre-operatively, day 0, day 3, day 10 and day 28) to characterize these phenomena.
Study Overview
Status
Unknown
Conditions
Detailed Description
Prostate brachytherapy is an effective treatment option for men with localized prostate cancer with excellent cure rates and a favorable toxicity profile.
Having a more detailed understanding of seed movement after an implant will provide clinicians with details about the clinical impact of these phenomena on implants and provide the detailed understanding of these phenomena that are necessary for more sophisticated brachytherapy implants that are envisioned in the future.
Study Type
Observational
Enrollment (Anticipated)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nawaid Usmani, MD, FRCPC
- Phone Number: 780-432-8518
- Email: Nawaid.Usmani@albertahealthservices.ca
Study Contact Backup
- Name: Ronald Sloboda, PhD
- Phone Number: 780-432-8719
- Email: Ron.Sloboda@albertahealthservices.ca
Study Locations
-
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Alberta
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Edmonton, Alberta, Canada, T6G 1Z2
- Recruiting
- Cross Cancer Institute
-
Contact:
- Nawaid Usmani, MD, FRCPC
- Phone Number: 780-432-8518
- Email: Nawaid.Usmani@albertahealthservices.ca
-
Contact:
- Ron Sloboda, PHD
- Phone Number: 780-432-8719
- Email: Ron.Sloboda@albertahealthservices.ca
-
Principal Investigator:
- Nawaid Usmani
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients seen at an academic institution (tertiary centre ...Cross Cancer Institute) for consideration of prostate brachytherapy
Description
Inclusion Criteria:
- treated with prostate brachytherapy
- low risk or intermediate risk prostate cancer
- ambulatory
- stable medical condition
- 18 years of age or older
- capable of informed consent
Exclusion Criteria:
- no use of any hormonal therapy
- unable to have MRI scans (ie. presence of metallic foreign object, aneurysm clip, cardiac pacemaker, internal wires, implanted pump, implanted cardiac device, claustrophobia, etc.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nawaid Usmani, MD, FRCPC, University of Alberta
- Principal Investigator: Ronald Sloboda, PhD, University of Alberta
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2011
Primary Completion (Anticipated)
June 1, 2015
Study Completion (Anticipated)
June 1, 2015
Study Registration Dates
First Submitted
May 16, 2011
First Submitted That Met QC Criteria
May 17, 2011
First Posted (Estimate)
May 18, 2011
Study Record Updates
Last Update Posted (Estimate)
October 3, 2014
Last Update Submitted That Met QC Criteria
October 1, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25750
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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