Markerless Image Guidance Using Intrafraction Kilovoltage X-ray Imaging

Overview

This trial will investigate the feasibility of the Markerless Tumour Tracking technology.

Full Title of Study: “MAGIK: Using Implanted Markers to Determine the Feasibility of Markerless Image Guidance Using Intrafraction Kilovoltage X-ray Imaging: A Phase I Interventional Study of Lung Cancer Radiotherapy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2021

Detailed Description

Markerless Tumour Tracking will be integrated with existing treatment machines to provide real-time monitoring of tumour motion during treatment delivery. Eligible patients will be implanted with fiducial markers, which act as the ground truth for evaluating the accuracy of Markerless Tumour Tracking. The patients will undergo the current standard of care radiotherapy, with the exception that kilovoltage x-ray images will be acquired continuously during treatment delivery to enable Markerless Tumour Tracking.

Interventions

  • Device: Markerless Image Guidance
    • Single arm trial using implanted markers to determine the feasibility of Markerless Image Guidance using Intrafraction Kilovoltage X-ray Imaging

Arms, Groups and Cohorts

  • Experimental: Markerless Image Guidance Arm
    • Single arm trial using implanted markers to determine the feasibility of Markerless Image Guidance using Intrafraction Kilovoltage X-ray Imaging

Clinical Trial Outcome Measures

Primary Measures

  • Markerless Tumour Tracking is feasible for motion-adaptive lung cancer radiotherapy
    • Time Frame: 2 years
    • This will be measured by 90% of the treatment fractions achieving: Continuous on-line tracking with no software failure; Agreement between markerless and marker-based tracking within 3 mm in each direction (left-right, superior-inferior, anterior-posterior) for at least 80% of the beam-on time as assessed in off-line analyses.

Participating in This Clinical Trial

Inclusion Criteria

  • Is willing to comply with all trial procedures and intends to provide written Informed Consent for participation in this trial.
  • Patients undergoing external beam radiotherapy.
  • Histologically proven Stage I NSCLC or oligometastatic lung metastases (3 or less).
  • MRI/4D-CT prior to insertion of fiducial markers.
  • Patient must be able to have fiducial markers placed in the lung (if on anticoagulants, must be cleared by LMO or cardiologist).
  • ECOG performance status 0-2.
  • A maximum of three metastases to the lung from any non-haematological malignancy. Multiple metastases will be treated separately.
  • 1 cm ≤ Tumour diameter in any dimension ≤ = 5 cm.
  • The distance between the tumour centroid and the top end of the diaphragm is <=10 cm.

Exclusion Criteria

  • Patient has low respiratory performance as evaluated by the physicians.
  • Previous high-dose thoracic radiotherapy.
  • Less than one fiducial marker implanted in the lung.
  • Fiducial markers are too far from the tumour centroid (>9 cm).
  • Cytotoxic chemotherapy within 3 weeks of commencement of treatment, or concurrently with treatment. Hormonal manipulation agents are allowable (e.g. aromatase inhibitors, selective oestrogen receptor modulators, and gonadotropin releasing hormone receptor modulators).
  • Targeted agents (such as sunitinib, bevacizumab and tarceva) within 7 days of commencement of treatment, or concurrently with treatment.
  • Women who are pregnant or lactating.
  • Unwilling or unable to complete quality of life questionnaires.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Sydney
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Paul Keall, PhD, Principal Investigator, University of Sydney
  • Overall Contact(s)
    • Shona Silvester, MSc, +61 2 8627 1185, shona.silvester@sydney.edu.au

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