MArkerless image Guidance using Intrafraction Kilovoltage x-ray imaging (MAGIK): Study protocol for a phase i interventional study for lung cancer radiotherapy

Marco Mueller, Jeremy Booth, Adam Briggs, Dasantha Jayamanne, Vanessa Panettieri, Sashendra Senthi, Chun Chien Shieh, Paul Keall

Research output: Contribution to journalArticleOtherpeer-review

1 Citation (Scopus)

Abstract

Introduction In radiotherapy, tumour tracking leads the radiation beam to accurately target the tumour while it moves in a complex and unpredictable way due to respiration. Several tumour tracking techniques require the implantation of fiducial markers around the tumour, a procedure that involves unnecessary risks and costs. Markerless tumour tracking (MTT) negates the need for implanted markers, potentially enabling accurate and optimal radiotherapy in a non-invasive way. Methods and analysis We will perform a phase I interventional trial called MArkerless image Guidance using Intrafraction Kilovoltage x-ray imaging (MAGIK) to investigate the technical feasibility of the MTT technology developed at the University of Sydney (sponsor). 30 participants will undergo the current standard of care lung stereotactic ablative radiation therapy, with the exception that kilovoltage X-ray images will be acquired continuously during treatment delivery to enable MTT. If MTT indicates that the mean lung tumour position has shifted >3 mm, a warning message will be displayed to indicate the need for a treatment intervention. The radiation therapist will then pause the treatment, shift the treatment couch to account for the shift in tumour position and resume the treatment. Participants will be implanted with fiducial markers, which act as the ground truth for evaluating the accuracy of MTT. MTT is considered feasible if the tracking accuracy is <3 mm in each dimension for >80% of the treatment time. Ethics and dissemination The MAGIK trial has received ethical approval from The Alfred Human Research Ethics Committee and has been registered with ClinicalTrials.gov with the Identifier: NCT04086082. Estimated time of first recruitment is early 2022. The study recruitment and data analysis phases will be performed concurrently. Treatment for all 30 participants is expected to be completed within 2 years and participant follow-up within a total duration of 7 years. Findings will be disseminated through peer-reviewed publications and conference presentations. Trial registration number NCT04086082; Pre-result.

Original languageEnglish
Article numbere21057135
Number of pages8
JournalBMJ Open
Volume12
Issue number1
DOIs
Publication statusPublished - 20 Jan 2022
Externally publishedYes

Keywords

  • medical physics
  • radiation oncology
  • radiotherapy

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