Non-invasive tracking of lung tumors during radiotherapy

Validation of Markerless Image Guidance Using Intrafraction Kolovoltage X-ray Imaging Using Implanted Fiducials: Phase I Observational Study of Lung Cancer Radiotherapy

This study is testing a new way to track lung tumors during radiation treatment without needing any implants, to see if it can help doctors monitor the tumors more accurately.

Quick facts

• Study type: Observational
• Enrollment: 10 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Royal North Shore Hospital (Academic / other)
• Drugs / interventions: bevacizumab, sunitinib, chemotherapy, radiation
• Locations: 1 site (Saint Leonards, New South Wales)
• Trial ID: NCT04310891 on ClinicalTrials.gov

What this trial studies

This observational trial investigates the feasibility of Markerless Tumour Tracking technology in lung cancer radiotherapy. By integrating this technology with existing treatment machines, the study aims to provide real-time monitoring of tumor motion without the need for implanted fiducial markers. Patients undergoing standard external beam radiotherapy will have continuous kilovoltage x-ray images acquired during treatment, which will be used to evaluate the accuracy of the Markerless Tumour Tracking system. The focus is on estimating the proportion of treatment time that the tracking remains within acceptable limits.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 or older with histologically proven Stage I non-small cell lung cancer or oligometastatic lung metastases who can have fiducial markers placed.

Not a fit: Patients with low respiratory performance or those who have previously received high-dose thoracic radiotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance the precision of lung cancer radiotherapy, potentially improving treatment outcomes and reducing side effects.

How similar studies have performed: While the concept of markerless tracking is innovative, similar studies have shown promise in improving tumor tracking accuracy, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

1. Aged 18 or older.
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:

1. Patient has low respiratory performance as evaluated by the physicians.
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.

Where this trial is running

Saint Leonards, New South Wales

• Royal North Shore Hospital — Saint Leonards, New South Wales, Australia (Recruiting)

Study contacts

• Principal investigator: Dasantha Jayamanne, MD — Royal North Shore Hospital
• Study coordinator: Carol Kwong, RN

Conditions Lung Cancer; Markerless Image Guidance; Intrafraction Kolovoltage X-ray Imaging; Radiotherapy; Fiducials; Markerless Tumour Tracking