An Evaluation of Polymer Based Fiducials for Use in Imaging Patients Receiving Treatment for Prostate Cancer
NCT ID: NCT01478412
Last Updated: 2011-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
20 participants
OBSERVATIONAL
2011-12-31
Brief Summary
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Detailed Description
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1. Whether polymer-based markers can be adequately visualized on daily stereoscopic imaging compared to gold seed markers.
2. Whether polymer-based markers are visible on ultrasound imaging.
3. To determine if the polymer-based marker produces fewer artifacts on treatment planning CT scans than gold markers.
Conditions
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Keywords
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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Males with prostate adenocarcinoma
English speaking males with histologically confirmed prostate adenocarcinoma and diagnosis of low risk or intermediate risk prostate cancer.
Polymer based fiducial placement
Fiducial marker placement with rectal ultrasound imaging.
Interventions
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Polymer based fiducial placement
Fiducial marker placement with rectal ultrasound imaging.
Eligibility Criteria
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Inclusion Criteria
* diagnosis of low risk or intermediate risk prostate cancer
* approved for proton therapy treatment at CDH ProCure Proton Therapy Center
* prescribed and consented for the placement of fiducial markers into the prostate as part of the standard treatment procedure
* capable of receiving an MRI of the pelvis region for prostate localization
* the prostate gland of eligible patients must be capable of imaging from an anterior trans-abdominal ultrasound as determined by the treating investigator
* must be fluent in the English language; must be able to provide written study consent
Exclusion Criteria
* previous prostate cancer surgery including prostatectomy, hyperthermia and cryosurgery
* previous pelvic radiation for prostate cancer
* current grade 2 or above incontinence
* history of orthopedic procedures in the area of the treatment, specifically no prior hip replacement or procedure in which metallic or high density material remains which would be within stereoscopic kilovoltage imaging area
* prior permanent placement of any metallic or high density material within the prostate
* known allergy to ultrasonic gel
MALE
No
Sponsors
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John Chang, MD
OTHER
Responsible Party
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John Chang, MD
John Chang, MD
Principal Investigators
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John Chang, MD
Role: PRINCIPAL_INVESTIGATOR
ProCure Proton Therapy Center
Locations
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ProCure Proton Therapy Center
Warrenville, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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Lori A Abruscato, BS
Role: primary
Related Links
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ProCure Proton Therapy Center
Other Identifiers
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CHI-001
Identifier Type: -
Identifier Source: org_study_id