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
  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:


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:
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 April 16, 2014