Markerless Image Guidance Using Intrafraction Kilovoltage X-ray Imaging
Australia30 participantsStarted 2023-05-24
Plain-language summary
This trial will investigate the feasibility of the Markerless Tumour Tracking technology.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 u…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Markerless Tumour Tracking is feasible for motion-adaptive lung cancer radiotherapy