NCT04086082 Markerless Image Guidance Using Intrafraction Kilovoltage X-ray Imaging
| NCT ID | NCT04086082 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Sydney |
| Condition | Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-05-24 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2023-05-24 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This trial will investigate the feasibility of the Markerless Tumour Tracking technology.
Eligibility 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.
Contact & Investigator
Paul Keall, PhD
PRINCIPAL INVESTIGATOR
University of Sydney
Frequently Asked Questions
Who can join the NCT04086082 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04086082 currently recruiting?
Yes, NCT04086082 is actively recruiting participants. Contact the research team at shona.silvester@sydney.edu.au for enrollment information.
Where is the NCT04086082 trial being conducted?
This trial is being conducted at Melbourne, Australia.
Who is sponsoring the NCT04086082 clinical trial?
NCT04086082 is sponsored by University of Sydney. The principal investigator is Paul Keall, PhD at University of Sydney. The trial plans to enroll 30 participants.
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