An Evaluation of Polymer Based Fiducials for Use in Imaging Patients Receiving Treatment for Prostate Cancer (Clarity)

December 6, 2011 updated by: John Chang, MD

A Prospective Evaluation of Polymer Based Fiducials for Use in Imaging Patients Receiving Treatment for Prostate Cancer

This trial is to determine if prostate target delineation obtained through an ultrasound based system is equivalent in accuracy to the MRI image fusion, and if alignment correction vectors obtained from ultrasound imaging are of equivalent accuracy to orthogonal X-ray imaging for daily prostate positioning.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The investigators will also be assessing the following:

  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.

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 Locations

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Members of all races and ethnic groups are eligible for this trial. Since this is a prostate study, only males will be enrolled.

Description

Inclusion Criteria:

  • Histologically confirmed prostate adenocarcinoma
  • 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:

  • Evidence of a large TURP defect per investigator discretion
  • 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

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

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Males with prostate adenocarcinoma
English speaking males with histologically confirmed prostate adenocarcinoma and diagnosis of low risk or intermediate risk prostate cancer.
Other: Polymer based fiducial placement
Fiducial marker placement with rectal ultrasound imaging.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ultrasound versus MRI image fusion for daily prostate positioning
Time Frame: 4 months
Determine if prostate target delineation obtained through an ultrasound based system is equivalent in accuracy to the MRI image fusion method, and if alighment crrection vectors obtained from ultransound imaging are of equivalent accuracy to orthogonal X-ray imaging for daily prostate positioning.
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Polymer based marker visualization
Time Frame: 4 months
To determine if polymer based markers can be adequately visualized on daily stereoscopic imaging compared to gold seed markers
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

John Chang, MD

Investigators

  • Principal Investigator: John Chang, MD, ProCure Proton Therapy Center

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.

Helpful Links

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

December 1, 2011

Study Registration Dates

First Submitted

November 21, 2011

First Submitted That Met QC Criteria

November 22, 2011

First Posted (Estimate)

November 23, 2011

Study Record Updates

Last Update Posted (Estimate)

December 7, 2011

Last Update Submitted That Met QC Criteria

December 6, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHI-001

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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