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Continuous Monitoring of Prostate Position During Radiotherapy (KIM Gating)

This study is not yet open for participant recruitment.
Verified June 2013 by Royal North Shore Hospital
Sponsor:
Information provided by (Responsible Party):
Dr. Thomas Eade, Royal North Shore Hospital
ClinicalTrials.gov Identifier:
NCT01742403
First received: December 2, 2012
Last updated: June 3, 2013
Last verified: June 2013
History of Changes
  Purpose

This study is investigating measurement of prostate motion during radiotherapy using the implanted gold markers. If motion is greater than 3mm then the beam will be stopped and position corrected (gating).


Condition Intervention Phase
Prostate Cancer
 Radiation: Prostate cancer radiotherapy gating using kV intrafraction monitoring (KIM)
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Feasibility Study of Prostate Cancer Radiotherapy Gating Using kV Intrafraction Monitoring (KIM)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Royal North Shore Hospital:

Primary Outcome Measures:
  • Feasibility [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Technique will be determined as feasible if 90% of treatment fractions are successfully segmented in real time.


Secondary Outcome Measures:
  • Time for procedure [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Measurement of time taken to perform KIM gating to guide future department resource questions.


Estimated Enrollment: 30
Study Start Date: January 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Radiotherapy gating using kV intrafraction monitoring Radiation: Prostate cancer radiotherapy gating using kV intrafraction monitoring (KIM)

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing definitive external beam radiotherapy;
  • Histological proven prostate adenocarcinoma
  • Prostate Specific Antigen (PSA),within 3 months prior to enrolment
  • Patient must be able to have gold fiducial markers placed in the prostate (if on anticoagulants, must be approved for procedure by Cardiologist)
  • ECOG 0-2
  • Ability to understand and willingness to sign informed consent form.

Exclusion Criteria:

  • Lymph node irradiation
  • Altered fractionation
  • Artificial hip(s)
  • Patient Dimensions <50cm
  • Overlapping fiducials (for segmentation)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01742403

Contacts
Contact: Thomas N Eade, MBBS +61294631319 TEade@nsccahs.health.nsw.gov.au
Contact: Jeremy Booth, PhD +61294631320 JBooth@nsccahs.health.nsw.gov.au

Locations
Australia, New South Wales
Department of Radiation Oncology, Northern Sydney Cancer Centre Not yet recruiting
St. Leonards, New South Wales, Australia, 2065
Contact: Thomas N Eade, MBBS     +61294631315     TEade@nsccahs.health.nsw.gov.au    
Principal Investigator: Thomas N Eade, RANZCR I & II            
Sponsors and Collaborators
Royal North Shore Hospital
Investigators
Principal Investigator: Thomas Eade, MBBS Royal North Shore Hospital
  More Information

No publications provided

Responsible Party: Dr. Thomas Eade, Radiation Oncologist, Royal North Shore Hospital
ClinicalTrials.gov Identifier: NCT01742403     History of Changes
Other Study ID Numbers: 12-NSCCRO-P001
Study First Received: December 2, 2012
Last Updated: June 3, 2013
Health Authority: Australia: Human Research Ethics Committee
Australia: National Health and Medical Research Council
Australia: Therapeutic Goods Administration

Keywords provided by Royal North Shore Hospital:
Prostate
IGRT
VMAT

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on June 18, 2013