search
Back to results

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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Goldlock
Visicoil smallest size
Visicoil larger size
Bard goldmarker smallest size
Bard goldmarker larger size
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Ghent

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

1

2

3

4

5

Arm Description

Goldlock

Visicoil smallest size

Visicoil larger size

Bard goldmarker smallest size

Bard goldmarker larger size

Outcomes

Primary Outcome Measures

Acute toxicity after implantation of the fiducial gold markers

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
Visualization of the implanted gold markers by ultrasound

Full Information

First Posted
February 10, 2009
Last Updated
January 3, 2023
Sponsor
University Hospital, Ghent
Collaborators
IBA, Germany, Hospimed, Netherland, Bard Ltd
search

1. Study Identification

Unique Protocol Identification Number
NCT00841685
Brief Title
The Implantation Under Echography of Fiducial Markers in the Intraprostatic Lesion and Prostate
Official Title
The Implantation Under Echography of Fiducial Markers in the Intraprostatic Lesion and Prostate
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
December 2008 (Actual)
Primary Completion Date
May 1, 2012 (Actual)
Study Completion Date
May 1, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
IBA, Germany, Hospimed, Netherland, Bard Ltd

4. Oversight

Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Goldlock
Arm Title
2
Arm Type
Active Comparator
Arm Description
Visicoil smallest size
Arm Title
3
Arm Type
Active Comparator
Arm Description
Visicoil larger size
Arm Title
4
Arm Type
Active Comparator
Arm Description
Bard goldmarker smallest size
Arm Title
5
Arm Type
Active Comparator
Arm Description
Bard goldmarker larger size
Intervention Type
Device
Intervention Name(s)
Goldlock
Intervention Description
Insertion of Goldlock marker
Intervention Type
Device
Intervention Name(s)
Visicoil smallest size
Intervention Description
Insertion of Visicoil, smallest size, marker
Intervention Type
Device
Intervention Name(s)
Visicoil larger size
Intervention Description
Insertion of Visicoil, larger size, marker
Intervention Type
Device
Intervention Name(s)
Bard goldmarker smallest size
Intervention Description
Insertion of Bard goldmarker, smallest size
Intervention Type
Device
Intervention Name(s)
Bard goldmarker larger size
Intervention Description
Insertion of Bard goldmarker, larger size
Primary Outcome Measure Information:
Title
Acute toxicity after implantation of the fiducial gold markers
Time Frame
1 week after implantation
Secondary Outcome Measure Information:
Title
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
Title
Visualization of the implanted gold markers by ultrasound
Time Frame
After implantation

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gert De Meerleer, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Links:
URL
http://www.uzgent.be
Description
Website of the University Hospital Ghent

Learn more about this trial

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

We'll reach out to this number within 24 hrs