Lung CancerMAGIKNCT04086082
Markerless Image Guidance Using Intrafraction Kilovoltage X-ray Imaging
A study testing Markerless Image Guidance in people with Lung Cancer, run by University of Sydney at 1 site in Australia.
Trial summary
This trial will investigate the feasibility of the Markerless Tumour Tracking technology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Markerless Image Guidance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteAustralia
- Study dates
- 24 May 2023to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Alfred Health
Melbourne, Victoria, 3004
Carole Owens, +61 3 90762174, c.owens@alfred.org.au
Sashendra Senthi, PhD
About this study
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
This trial will investigate the feasibility of the Markerless Tumour Tracking technology.
Read the 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 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.
- Conditions
- Lung Cancer
- Being tested
- Markerless Image Guidance
- Keywords
- Lung cancer, NSCLC, Oligometastases
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Markerless Image GuidanceDevice
Single arm trial using implanted markers to determine the feasibility of Markerless Image Guidance using Intrafraction Kilovoltage X-ray Imaging
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Markerless Image Guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start24 May 2023
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sydney
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Keall, PhD, Principal investigator, University of Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04086082
- Sponsor's protocol ID
- MAGIK V1.0
- Acronym
- MAGIK
- Status last verified
- May 2026
- First submitted
- 6 May 2019
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data and images will be made available for other scientific research.
Publications
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.
PubMed 35058267
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04086082
- Acronym / sponsor ID
- MAGIK / MAGIK V1.0
- Conditions
- Lung Cancer
- Keywords
- Lung cancer, NSCLC, Oligometastases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of SydneyUniversity, hospital or other
- Study start
- 24 May 2023 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 11 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Markerless Image Guidance Arm | Experimental | Device: Markerless Image GuidanceSingle arm trial using implanted markers to determine the feasibility of Markerless Image Guidance using Intrafraction Kilovoltage X-ray Imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Markerless Image GuidanceSingle arm trial using implanted markers to determine the feasibility of Markerless Image Guidance using Intrafraction Kilovoltage X-ray Imaging | Device | Markerless Image Guidance Arm |
Primary outcome
Markerless Tumour Tracking is feasible for motion-adaptive lung cancer radiotherapy
Time frame: 2 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Derived from this study: PubMed 35058267Mueller 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.
- Individual participant dataSharing planned: Yes. De-identified participant data and images will be made available for other scientific research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul Keall, PhD principal investigator
University of Sydney
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Markerless Image Guidance in people with Lung Cancer, run by University of Sydney at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial Coordinator (+61 2 8627 1185, shona.silvester@sydney.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Markerless Tumour Tracking is feasible for motion-adaptive lung cancer radiotherapy (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04086082, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.