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

Prostate Adenocarcinoma Clinical Trial

— Clarity  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01478412
• Other study ID #: CHI-001
• Status: Recruiting
• Phase: N/A
• First received: November 21, 2011
• Last updated: December 6, 2011
• Start date: December 2011

Study information

• Verified date: December 2011
• Source: ProCure Proton Therapy Center
• Contact: Lori A Abruscato, BS
• Phone: 630-821-6397
• Email: lori.abruscato[@]chi.procure.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Adenocarcinoma
• Prostate Adenocarcinoma
• Prostatic Neoplasms

Intervention

Other:
• Polymer based fiducial placement
Fiducial marker placement with rectal ultrasound imaging.

Locations

Country	Name	City	State
United States	ProCure Proton Therapy Center	Warrenville	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
John Chang, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ultrasound versus MRI image fusion for daily prostate positioning	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	No
Secondary	Polymer based marker visualization	To determine if polymer based markers can be adequately visualized on daily stereoscopic imaging compared to gold seed markers	4 months	No