RecruitingNot ApplicableNCT04086082
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
Sponsor
University of Sydney
Enrollment
30 participants
Start Date
May 24, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
This trial will investigate the feasibility of the Markerless Tumour Tracking technology.
Eligibility
Min Age: 18 Years
Inclusion Criteria9
- 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.
- 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 Criteria8
- 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.
Interventions
DEVICEMarkerless Image Guidance
Single arm trial using implanted markers to determine the feasibility of Markerless Image Guidance using Intrafraction Kilovoltage X-ray Imaging
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04086082
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