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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by University Hospital, Ghent
Sponsor:
Collaborators:
IBA, Germany
Hospimed, Netherland
Bard Ltd
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00841685
First received: February 10, 2009
Last updated: December 4, 2014
Last verified: December 2014
History of Changes

February 10, 2009
December 4, 2014
December 2008
May 2015   (final data collection date for primary outcome measure)
Acute toxicity after implantation of the fiducial gold markers [ Time Frame: 1 week after implantation ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00841685 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
The Implantation Under Echography of Fiducial Markers in the Intraprostatic Lesion and Prostate
The Implantation Under Echography of Fiducial Markers in the Intraprostatic Lesion and Prostate
Implantation of fiducial markers in the prostate and daily check of the positioning during radiotherapy based on the implanted fiducial markers
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Prostate Cancer
  • Device: Goldlock
    Insertion of Goldlock marker
  • Device: Visicoil smallest size
    Insertion of Visicoil, smallest size, marker
  • Device: Visicoil larger size
    Insertion of Visicoil, larger size, marker
  • Device: Bard goldmarker smallest size
    Insertion of Bard goldmarker, smallest size
  • Device: Bard goldmarker larger size
    Insertion of Bard goldmarker, larger size
  • Experimental: 1
    Goldlock
    Intervention: Device: Goldlock
  • Active Comparator: 2
    Visicoil smallest size
    Intervention: Device: Visicoil smallest size
  • Active Comparator: 3
    Visicoil larger size
    Intervention: Device: Visicoil larger size
  • Active Comparator: 4
    Bard goldmarker smallest size
    Intervention: Device: Bard goldmarker smallest size
  • Active Comparator: 5
    Bard goldmarker larger size
    Intervention: Device: Bard goldmarker larger size
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
May 2015
May 2015   (final data collection date for primary outcome measure)

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
Male
18 Years and older   (Adult, Senior)
No
Contact: Valérie Fonteyne, MD Valerie.fonteyne@uzgent.be
Belgium
 
NCT00841685
2008/109
No
Not Provided
Not Provided
University Hospital, Ghent
University Hospital, Ghent
  • IBA, Germany
  • Hospimed, Netherland
  • Bard Ltd
Principal Investigator: Gert De Meerleer, MD, PhD University Hospital, Ghent
University Hospital, Ghent
December 2014

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