Markerless Image Guidance Using Intrafraction Kilovoltage X-ray Imaging

NCT04086082 | Recruiting

• 1 other identifier: MAGIK V1.0
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lung Cancer

Keywords

Lung cancer; NSCLC; Oligometastases

Outcome Measures

Primary Outcomes (1)

• Markerless Tumour Tracking is feasible for motion-adaptive lung cancer radiotherapy

  This will be measured by 90% of the treatment fractions achieving: 1. Continuous on-line tracking with no software failure; 2. 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

Study Arms (1)

Markerless Image Guidance Arm

EXPERIMENTAL

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

Device: Markerless Image Guidance

Interventions

Markerless Image Guidance DEVICE

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

Markerless Image Guidance Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• cm ≤ Tumour diameter in any dimension ≤ = 5 cm.
• The distance between the tumour centroid and the top end of the diaphragm is \<=10 cm.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sydney: lead

Study Sites (1)

Alfred Health

Melbourne, Victoria, 3004, Australia

RECRUITING

Related Publications (1)

• Mueller M, Booth J, Briggs A, Jayamanne D, Panettieri V, Senthi S, Shieh CC, Keall P. MArkerless image Guidance using Intrafraction Kilovoltage x-ray imaging (MAGIK): study protocol for a phase I interventional study for lung cancer radiotherapy. BMJ Open. 2022 Jan 20;12(1):e057135. doi: 10.1136/bmjopen-2021-057135.

  PMID: 35058267 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Paul Keall, PhD

  University of Sydney

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Trial Coordinator

CONTACT

+61 2 8627 1185; shona.silvester@sydney.edu.au

Research Student

CONTACT

+61 2 8627 1185; Jonathan.Hindmarsh@sydney.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: September 11, 2019
• Study Start: May 24, 2023
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be made available following publication of the final analysis, and for a minimum of 2 years thereafter.
• Access Criteria: Requests must be made to the original researchers for access to the data.

Locations

AU (1)