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The Implantation Under Echography of Fiducial Markers in the Intraprostatic Lesion and Prostate

This study is currently recruiting participants.
Verified February 2013 by University Hospital, Ghent
Sponsor:
Collaborators:
IBA, Germany
Hospimed, Netherland
C. R. Bard
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00841685
First received: February 10, 2009
Last updated: February 1, 2013
Last verified: February 2013
History of Changes
  Purpose

Implantation of fiducial markers in the prostate and daily check of the positioning during radiotherapy based on the implanted fiducial markers


Condition Intervention
Prostate Cancer
 Device: Goldlock
Device: Visicoil smallest size
Device: Visicoil larger size
Device: Bard goldmarker smallest size
Device: Bard goldmarker larger size

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: The Implantation Under Echography of Fiducial Markers in the Intraprostatic Lesion and Prostate

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Acute toxicity after implantation of the fiducial gold markers [ Time Frame: 1 week after implantation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Feasibility of insertion 1 fiducial gold marker in the intraprostatic lesion combined with extra gold markers in the rest of the prostate upto 3 goldmarkers in total [ Time Frame: 1 week after implantation ] [ Designated as safety issue: Yes ]
  • Visualization of the implanted gold markers by ultrasound [ Time Frame: After implantation ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: December 2008
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Goldlock
 Device: Goldlock
Insertion of Goldlock marker
Active Comparator: 2
Visicoil smallest size
 Device: Visicoil smallest size
Insertion of Visicoil, smallest size, marker
Active Comparator: 3
Visicoil larger size
 Device: Visicoil larger size
Insertion of Visicoil, larger size, marker
Active Comparator: 4
Bard goldmarker smallest size
 Device: Bard goldmarker smallest size
Insertion of Bard goldmarker, smallest size
Active Comparator: 5
Bard goldmarker larger size
 Device: Bard goldmarker larger size
Insertion of Bard goldmarker, larger size

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • histological proven adenocarcinoma of the prostate
  • T1-T4 tumors
  • Radiotherapy as primary therapy +/- androgen deprivation
  • Presence of an intraprostatic lesion (IPL) on MRI/MRS
  • Presence of an intraprostatic lesion (IPL) on ultrasound
  • WHO 0-2

Exclusion Criteria:

  • Other primary tumor, except non-melanoma skin cancer
  • No written informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00841685

Contacts
Contact: Valérie Fonteyne, MD Valerie.fonteyne@uzgent.be

Locations
Belgium
University Hospital Ghent Recruiting
Ghent, Belgium, 9000
Principal Investigator: Gert De Meerleer, MD, PhD            
Sub-Investigator: Valérie Fonteyne, MD            
Sponsors and Collaborators
University Hospital, Ghent
IBA, Germany
Hospimed, Netherland
C. R. Bard
Investigators
Principal Investigator: Gert De Meerleer, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
Website of the University Hospital Ghent  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00841685     History of Changes
Other Study ID Numbers: 2008/109
Study First Received: February 10, 2009
Last Updated: February 1, 2013
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on June 18, 2013