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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified December 2014 by University Hospital, Ghent.
Recruitment status was: Recruiting

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

Tracking Information

First Received Date ^ICMJE

February 10, 2009

Last Updated Date

December 4, 2014

Start Date ^ICMJE

December 2008

Estimated Primary Completion Date

May 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00841685 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]
Visualization of the implanted gold markers by ultrasound [ Time Frame: After implantation ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)

Condition ^ICMJE

Prostate Cancer

Intervention ^ICMJE

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

Study Arms

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Unknown status

Estimated Enrollment ^ICMJE

Estimated Completion Date

May 2015

Estimated Primary Completion Date

May 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

Male

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Belgium

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00841685

Other Study ID Numbers ^ICMJE

2008/109

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

University Hospital, Ghent

Study Sponsor ^ICMJE

University Hospital, Ghent

Collaborators ^ICMJE

IBA, Germany
Hospimed, Netherland
Bard Ltd

Investigators ^ICMJE

Principal Investigator:

Gert De Meerleer, MD, PhD

University Hospital, Ghent

PRS Account

University Hospital, Ghent

Verification Date

December 2014

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

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