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OpenTrials
Completed

NCT Number: NCT00841685

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

Completed

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Ghent

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Goldlock

Device

Insertion of Goldlock marker

Visicoil smallest size

Device

Insertion of Visicoil, smallest size, marker

Visicoil larger size

Device

Insertion of Visicoil, larger size, marker

Bard goldmarker smallest size

Device

Insertion of Bard goldmarker, smallest size

Bard goldmarker larger size

Device

Insertion of Bard goldmarker, larger size

Primary outcomes

  1. Acute toxicity after implantation of the fiducial gold markers

    Time frame: 1 week after implantation

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • Bard Ltd
  • Hospimed, Netherland
  • IBA, Germany

Registry information

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Feb 11, 2009
Registry last updated
Jan 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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