Clinical trial · Interventional
Markerless Image Guidance Using Intrafraction Kilovoltage X-ray Imaging
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
NCT04086082CI-TRIAL-00112096MAGIKrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This trial will investigate the feasibility of the Markerless Tumour Tracking technology.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Markerless Image Guidance | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Markerless Image Guidance Arm
- description
- Single arm trial using implanted markers to determine the feasibility of Markerless Image Guidance using Intrafraction Kilovoltage X-ray Imaging
- interventionNames
- Device: Markerless Image Guidance
Primary outcomes (1)
- measure
- Markerless Tumour Tracking is feasible for motion-adaptive lung cancer radiotherapy
- timeFrame
- 2 years
- description
- This will be measured by 90% of the treatment fractions achieving: 1. Continuous on-line tracking with no software failure; 2. 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDMueller M, Booth J, Briggs A, Jayamanne D, Panettieri V, Senthi S, Shieh CC, Keall P. MArkerless image Guidance using Intrafraction Kilovoltage x-ray imaging (MAGIK): study protocol for a phase I interventional study for lung cancer radiotherapy. BMJ Open. 2022 Jan 20;12(1):e057135. doi: 10.1136/bmjopen-2021-057135. PMID 35058267