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Multi-target Tracking in Prostate Radiotherapy Using MLC and KIM

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ClinicalTrials.gov Identifier: NCT02588846
Recruitment Status : Not yet recruiting
First Posted : October 28, 2015
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Associate Professor Thomas Eade, Royal North Shore Hospital

Brief Summary:
Assessing the feasibility of implementing real-time multi-leaf collimator (MLC) tracking to account for the relative motion of the moving prostate tumour target and the static pelvic nodal target for high-risk prostate cancer patients. The capability of tracking for the relative motion of multiple targets will ensure that all the treatment targets receive correct dose as prescribed by the doctor and minimise side effects to the critical organs.

Condition or disease Intervention/treatment Phase
Prostate Cancer Device: Combined real-time use of 'Multi-Leaf Collimator Adaptation' and 'kV Intrafraction Monitoring' Not Applicable

Detailed Description:

This study will assess the feasibility of implementing real-time multi-leaf collimator (MLC) tracking to account for the relative motion of the moving prostate tumour target and the static pelvic nodal target for high-risk prostate cancer patients. The capability of tracking for the relative motion of multiple targets will ensure that all the treatment targets receive correct dose as prescribed by the doctor and minimising side effects to the critical organs.

During radiation treatment, the prostate position will be monitored in real time using the KIM technology. The nodal target will be imaged before and after each treatment to evaluate the nodal treatment margin. The MLC tracking is implemented by recalculating the radiation beam shape fit for the moved prostate and static nodal targets and sending the adjusted MLC leaf positions to the treatment delivery system. The actually delivered dose to the patient will be calculated after the treatment and compared to the dose without MLC tracking to assess the treatment efficacy.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: All patients receive the intervention for comparison against retrospective matched cohort.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Feasibility Study of Accounting for Relative Motion of Multiple Targets in Prostate Cancer Radiotherapy Using Realtime Multi-leaf Collimator Adaptation and Kilovoltage (kV) Intrafraction Monitoring
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Stage 1: Optimise nodal treatment margin
During Stage 1: Optimise nodal treatment margin, Combined real-time use of 'Multi-Leaf Collimator Adaptation' and 'kV Intrafraction Monitoring' will be used to reshape the radiation beam in real-time. The nodal target position stability will be evaluated by the cone beam computed tomography (CBCT) imaging before and after each treatment session for the first 10 patients.
Device: Combined real-time use of 'Multi-Leaf Collimator Adaptation' and 'kV Intrafraction Monitoring'
This intervention uses the simultaneous combined use of two technologies: 'Multi-Leaf Collimator Adaptation' and 'kV Intrafraction Monitoring'. kV Intrafraction Monitoring (KIM) measures the motion of tissues targeted for radiotherapy in real time using kV imaging.The multi-leaf collimator (MLC) reshapes the radiation beam to maximise dose to the target tissue and minimise dose to the surrounding healthy tissue. Combining KIM and MLC allows the shaped radiation beam to follow the moving target (the prostate) while remaining fixed on a stationary target (lymph nodes) that are also being treated at the same time.
Other Names:
  • MLC
  • KIM

Experimental: Stage 2: Use treatment margin
During Stage 2: Use treatment margin, Combined real-time use of 'Multi-Leaf Collimator Adaptation' and 'kV Intrafraction Monitoring' will be used to reshape the radiation beam in real-time. At the same time, multi-leaf collimator (MLC) tracking will be used to reshape the radiation beam in real-time using the margin size determined in Stage 1.
Device: Combined real-time use of 'Multi-Leaf Collimator Adaptation' and 'kV Intrafraction Monitoring'
This intervention uses the simultaneous combined use of two technologies: 'Multi-Leaf Collimator Adaptation' and 'kV Intrafraction Monitoring'. kV Intrafraction Monitoring (KIM) measures the motion of tissues targeted for radiotherapy in real time using kV imaging.The multi-leaf collimator (MLC) reshapes the radiation beam to maximise dose to the target tissue and minimise dose to the surrounding healthy tissue. Combining KIM and MLC allows the shaped radiation beam to follow the moving target (the prostate) while remaining fixed on a stationary target (lymph nodes) that are also being treated at the same time.
Other Names:
  • MLC
  • KIM




Primary Outcome Measures :
  1. Software or mechanical failure [ Time Frame: The treatment period (2-9 weeks) ]
    The percentage of fractions delivered without software or mechanical failure


Secondary Outcome Measures :
  1. Geometric accuracy [ Time Frame: The treatment period (2-9 weeks) ]
    The geometric accuracy of the beam shape, determined by comparing the ideal beam shape with the actual beam shape.

  2. Prostate motion trajectory [ Time Frame: Treatment period (2-9 weeks) ]
    Prostate motion trajectory measured by KIM.

  3. Dosimetric accuracy [ Time Frame: Treatment period (2-9 weeks) ]
    The estimated dose distributions will be compared to the original plan using the dose reconstruction method18 based on the prostate motion trajectory and the logged MLC positions (beam shapes).

  4. Acute toxicity [ Time Frame: Treatment period (2-9 weeks) plus 3 months ]
    Toxicity during treatment



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing definitive external beam radiotherapy at Northern Sydney Cancer Centre
  • Patients histologically proven prostate adenocarcinoma
  • PSA obtained within 3 months prior to enrolment
  • Pelvic lymph nodes are included for treatment for patients at stage T1c-T3b with Gleason 8-10 or prostate-specific antigen (PSA) > 20 ng/ml or pelvic lymph node positivity on conventional imaging or prostate-specific membrane antigen (PSMA) scans.
  • Patient must be able to have gold fiducial markers placed in the prostate
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Ability to understand and the willingness to sign a written informed consent document.
  • Prostate dimension that allows leaf span with tracking margin of ±8mm

Exclusion Criteria:

  • Patients with artificial Hip(s), lumbar spinal surgical rods or other large metallic pelvic implants
  • Patient's dimensions >40cm as measured at the level of the prostate
  • Patients with overlapping implanted gold fiducials in x-ray imaging

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02588846


Contacts
Contact: Clare Banks, BASc MPH 1 2 9463 1345 Clare.Banks@health.nsw.gov.au
Contact: Carol Kwong, RN 61 2 9463 1339 Carolyn.Kwong@health.nsw.gov.au

Locations
Australia, New South Wales
Royal North Shore Hospital Not yet recruiting
St Leonards, New South Wales, Australia, 2065
Contact: Clare Banks, BASc, MPH    +61 2 9463 1340    Clare.Banks@health.nsw.gov.au   
Contact: Carol Kwong, RN    +61 2 9463 1339    Carolyn.Kwong@health.nsw.gov.au   
Sponsors and Collaborators
Royal North Shore Hospital
Investigators
Principal Investigator: Thomas Eade, MBBS, RANZCR Director of Research, Senior Staff Specialist

Responsible Party: Associate Professor Thomas Eade, Head of Research, Royal North Shore Hospital
ClinicalTrials.gov Identifier: NCT02588846     History of Changes
Other Study ID Numbers: Multi-target tracking
First Posted: October 28, 2015    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Share for research purposes with interested parties.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Associate Professor Thomas Eade, Royal North Shore Hospital:
Prostate
Radiotherapy
IGRT
VMAT
Image-guided radiation therapy
Volumetric modulated arc therapy
Adaptive radiotherapy

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