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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00841685
Recruitment Status : Unknown
Verified December 2014 by University Hospital, Ghent.
Recruitment status was:  Recruiting
First Posted : February 11, 2009
Last Update Posted : December 5, 2014
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Implantation of fiducial markers in the prostate and daily check of the positioning during radiotherapy based on the implanted fiducial markers

Condition or disease Intervention/treatment
Prostate Cancer Device: Goldlock Device: Visicoil smallest size Device: Visicoil larger size Device: Bard goldmarker smallest size Device: Bard goldmarker larger size

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: The Implantation Under Echography of Fiducial Markers in the Intraprostatic Lesion and Prostate
Study Start Date : December 2008
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Acute toxicity after implantation of the fiducial gold markers [ Time Frame: 1 week after implantation ]

Secondary Outcome Measures :
  1. 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 ]
  2. Visualization of the implanted gold markers by ultrasound [ Time Frame: After implantation ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Bard Ltd
Investigators
Principal Investigator: Gert De Meerleer, MD, PhD University Hospital, Ghent
More Information

Additional Information:
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00841685     History of Changes
Other Study ID Numbers: 2008/109
First Posted: February 11, 2009    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014