Markerless Image Guidance Using Intrafraction Kolovoltage X-ray Imaging for Lung Cancer Radiotherapy
NCT ID: NCT04310891
Last Updated: 2023-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
10 participants
OBSERVATIONAL
2020-12-04
2025-12-31
Brief Summary
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Detailed Description
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The trial will be a single-institution study recruiting only at RNSH Radiation Oncology Department.
As this trial investigates feasibility, our focus will be on estimating the proportion of treatment time in which the Markerless Tumour Tracking is within acceptable limits.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Markerless
Markerless Tumour Tracking will be used to observe the radiation beam is accurately targeting the tumour.
Markerless Tumour Tracking
Intrafraction Kolovoltage X-ray Imaging using Fiducials
Interventions
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Markerless Tumour Tracking
Intrafraction Kolovoltage X-ray Imaging using Fiducials
Eligibility Criteria
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Inclusion Criteria
2. Has provided written Informed Consent for participation in this trial and is willing to comply with the study.
3. Patients undergoing external beam radiotherapy.
4. Histologically proven Stage I NSCLC or oligometastatic lung metastases (3 or less).
5. Diagnostic CT prior to insertion of fiducial markers.
6. Patient must be able to have fiducial markers placed in the lung (if on anticoagulants, must be cleared by LMO or cardiologist).
7. ECOG performance status 0-2.
8. A maximum of three metastases to the lung from any non-haematological malignancy. Multiple metastases will be treated separately.
9. 1 cm ≤ Tumour diameter in any dimension ≤ = 5 cm.
10. The distance between the tumour centroid and the top end of the diaphragm is \<=8 cm.
Exclusion Criteria
2. Previous high-dose thoracic radiotherapy.
3. Less than one fiducial marker implanted in the lung.
4. Fiducial markers are too far from the tumour centroid (\>9 cm).
5. 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).
6. Targeted agents (such as sunitinib, bevacizumab and tarceva) within 7 days of commencement of treatment, concurrently with treatment or 7 days after radiotherapy.
7. Women who are pregnant or lactating.
8. Unwilling or unable to give informed consent.
9. Unwilling or unable to complete quality of life questionnaires.
18 Years
80 Years
ALL
No
Sponsors
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University of Sydney
OTHER
Royal North Shore Hospital
OTHER
Responsible Party
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Dasantha Jayamanne
Radiation Oncologist
Principal Investigators
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Dasantha Jayamanne, MD
Role: PRINCIPAL_INVESTIGATOR
Royal North Shore Hospital
Locations
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Royal North Shore Hospital
Saint Leonards, New South Wales, Australia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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VALKIM
Identifier Type: -
Identifier Source: org_study_id
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