An Evaluation of Polymer Based Fiducials for Use in Imaging Patients Receiving Treatment for Prostate Cancer (Clarity)
This study is currently recruiting participants.
Verified December 2011 by ProCure Proton Therapy Center
Sponsor:
John Chang, MD
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
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Prostate Adenocarcinoma |
Other: Polymer based fiducial placement |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Retrospective |
| Official Title: | A Prospective Evaluation of Polymer Based Fiducials for Use in Imaging Patients Receiving Treatment for Prostate Cancer |
Resource links provided by NLM:
Further study details as provided by ProCure Proton Therapy Center:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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
| Estimated Enrollment: | 20 |
| Study Start Date: | December 2011 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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.
|
Detailed Description:
The investigators will also be assessing the following:
- Whether polymer-based markers can be adequately visualized on daily stereoscopic imaging compared to gold seed markers.
- Whether polymer-based markers are visible on ultrasound imaging.
- To determine if the polymer-based marker produces fewer artifacts on treatment planning CT scans than gold markers.
Eligibility| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
| 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.
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01478412
Contacts
| Contact: Lori A Abruscato, BS | 630-821-6397 | lori.abruscato@chi.procure.com |
Locations
| United States, Illinois | |
| ProCure Proton Therapy Center | Recruiting |
| Warrenville, Illinois, United States, 60555 | |
| Contact: Lori A Abruscato, BS 630-821-6397 lori.abruscato@chi.procure.com | |
| Principal Investigator: John Chang, MD | |
Sponsors and Collaborators
John Chang, MD
Investigators
| Principal Investigator: | John Chang, MD | ProCure Proton Therapy Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | John Chang, MD, ProCure Proton Therapy Center |
| ClinicalTrials.gov Identifier: | NCT01478412 History of Changes |
| Other Study ID Numbers: | CHI-001 |
| Study First Received: | November 21, 2011 |
| Last Updated: | December 6, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by ProCure Proton Therapy Center:
|
Prostate cancer Low risk Intermediate risk T1 T2a |
T2b Gleason 6 Gleason 7 PSA 10 PSA 20 |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Prostatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Neoplasms, Cystic, Mucinous, and Serous Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on June 17, 2013