Real-time monitoring of lung tumors during radiotherapy
Official title: 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
Run by University of Sydney · NCT04086082 · Data updated 2026-11-12
This study is testing a new technology that tracks lung tumors in real-time during radiation treatment to see if it can make the treatment more precise for lung cancer patients.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | University of Sydney Academic / other |
| Drugs / interventions | bevacizumab, sunitinib, chemotherapy |
| Locations | 1 site (Melbourne, Victoria) |
| Status | Recruiting |
| Started | May 24, 2023 |
| Main results expected | December 2028 |
| Study ends | December 2028 |
| Registry record updated | May 20, 2026 |
| Trial ID | NCT04086082 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with Stage I non-small cell lung cancer or oligometastatic lung metastases who are undergoing external beam radiotherapy.
✕Probably not a fit
Patients with low respiratory performance or those who have previously received high-dose thoracic radiotherapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial investigates the feasibility of Markerless Tumour Tracking technology, which integrates with existing treatment machines to monitor tumor motion in real-time during radiotherapy. Patients will receive standard care while undergoing continuous kilovoltage x-ray imaging to evaluate the accuracy of this tracking method. The study aims to improve treatment precision for patients with lung cancer by using fiducial markers as a reference for tracking tumor movement.
Why it matters
Potential benefit: If successful, this approach could enhance the accuracy of lung cancer treatments, potentially leading to better patient outcomes.
How similar studies have gone: While the concept of real-time tumor tracking is being explored, this specific markerless approach is relatively novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Alfred Health
Melbourne, Victoria, Australia Recruiting
Study contacts
- Principal investigator: Paul Keall, PhD — University of Sydney
- Study coordinator: Trial Coordinator
- Email: shona.silvester@sydney.edu.au
- Phone: +61 2 8627 1185
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.