Markerless Image Guidance Using Intrafraction Kilovoltage X-ray Imaging

Lung Cancer Clinical Trial

— MAGIK  

Official title:

MAGIK: Using Implanted Markers to Determine the Feasibility of Markerless Image Guidance Using Intrafraction Kilovoltage X-ray Imaging: A Phase I Interventional Study of Lung Cancer Radiotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04086082
• Other study ID #: MAGIK V1.0
• Status: Recruiting
• Phase: N/A
• Start date: May 24, 2023
• Est. completion date: December 2028

Study information

• Verified date: January 2024
• Source: University of Sydney
• Contact: Trial Coordinator
• Phone: +61 2 8627 1185
• Email: shona.silvester[@]sydney.edu.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial will investigate the feasibility of the Markerless Tumour Tracking technology.

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 fiducial markers, which act as the ground truth for evaluating the accuracy of Markerless Tumour Tracking. The patients will undergo the current standard of care radiotherapy, with the exception that kilovoltage x-ray images will be acquired continuously during treatment delivery to enable Markerless Tumour Tracking.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2028
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Device:
• Markerless Image Guidance
Single arm trial using implanted markers to determine the feasibility of Markerless Image Guidance using Intrafraction Kilovoltage X-ray Imaging

Locations

Country	Name	City	State
Australia	Alfred Health	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
University of Sydney

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Markerless Tumour Tracking is feasible for motion-adaptive lung cancer radiotherapy	This will be measured by 90% of the treatment fractions achieving: Continuous on-line tracking with no software failure; Agreement between markerless and marker-based tracking within 3 mm in each direction (left-right, superior-inferior, anterior-posterior) for at least 80% of the beam-on time as assessed in off-line analyses.	2 years