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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by ProCure Proton Therapy Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
John Chang, MD, ProCure Proton Therapy Center
ClinicalTrials.gov Identifier:
NCT01478412
First received: November 21, 2011
Last updated: December 6, 2011
Last verified: December 2011

November 21, 2011
December 6, 2011
December 2011
Not Provided
Ultrasound versus MRI image fusion for daily prostate positioning [ Time Frame: 4 months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01478412 on ClinicalTrials.gov Archive Site
Polymer based marker visualization [ Time Frame: 4 months ] [ Designated as safety issue: No ]
To determine if polymer based markers can be adequately visualized on daily stereoscopic imaging compared to gold seed markers
Same as current
Not Provided
Not Provided
 
An Evaluation of Polymer Based Fiducials for Use in Imaging Patients Receiving Treatment for Prostate Cancer
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.

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.
Observational
Observational Model: Case-Only
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

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

Prostate Adenocarcinoma
Other: Polymer based fiducial placement
Fiducial marker placement with rectal ultrasound imaging.
Males with prostate adenocarcinoma
English speaking males with histologically confirmed prostate adenocarcinoma and diagnosis of low risk or intermediate risk prostate cancer.
Intervention: Other: Polymer based fiducial placement
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
Not Provided
Not Provided

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
Male
Not Provided
No
Contact: Lori A Abruscato, BS 630-821-6397 lori.abruscato@chi.procure.com
United States
 
NCT01478412
CHI-001
No
John Chang, MD, ProCure Proton Therapy Center
John Chang, MD
Not Provided
Principal Investigator: John Chang, MD ProCure Proton Therapy Center
ProCure Proton Therapy Center
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP