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NCT00841685 Clinical Trial

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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00841685
Other study ID # 2008/109
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 2008
Est. completion date May 1, 2012

Study information
Verified date January 2023
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date May 1, 2012
Est. primary completion date May 1, 2012
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Goldlock
Insertion of Goldlock marker
• Visicoil smallest size
Insertion of Visicoil, smallest size, marker
• Visicoil larger size
Insertion of Visicoil, larger size, marker
• Bard goldmarker smallest size
Insertion of Bard goldmarker, smallest size
• Bard goldmarker larger size
Insertion of Bard goldmarker, larger size

Locations
Country Name City State
Belgium University Hospital Ghent Ghent

Sponsors (4)
Lead Sponsor Collaborator
University Hospital, Ghent Bard Ltd, Hospimed, Netherland, IBA, Germany

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Acute toxicity after implantation of the fiducial gold markers 1 week after implantation
Secondary 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 1 week after implantation
Secondary Visualization of the implanted gold markers by ultrasound After implantation
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