Real-time monitoring of lung tumors during radiotherapy
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Sydney Academic / other |
| Drugs / interventions | bevacizumab, sunitinib, chemotherapy |
| Locations | 1 site (Melbourne, Victoria) |
| Trial ID | NCT04086082 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients with Stage I non-small cell lung cancer or oligometastatic lung metastases who are undergoing external beam radiotherapy.
Not a fit: Patients with low respiratory performance or those who have previously received high-dose thoracic radiotherapy may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Melbourne, Victoria
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.