Status:
RECRUITING
Markerless Image Guidance Using Intrafraction Kilovoltage X-ray Imaging
Lead Sponsor:
University of Sydney
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This trial will investigate the feasibility of the Markerless Tumour Tracking technology.
Detailed Description
Markerless Tumour Tracking will be integrated with existing treatment machines to provide real-time monitoring of tumour motion during treatment delivery. Eligible patients will be implanted with fidu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04086082
Start Date
May 24 2023
End Date
December 1 2028
Last Update
January 11 2024
Active Locations (1)
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1
Alfred Health
Melbourne, Victoria, Australia, 3004