Lung CancerVALKIMNCT04310891
Markerless Image Guidance Using Intrafraction Kolovoltage X-ray Imaging for Lung Cancer Radiotherapy
An observational study of Lung Cancer and Markerless Image Guidance, run by Royal North Shore Hospital at 1 site in Australia.
Trial summary
In radiotherapy, tumour tracking allows us to ensure the radiation beam is accurately targeting the tumour while it moves in a complex and unpredictable way. Most tumour tracking techniques require the implantation of fiducial markers around the tumour. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Cancer, Markerless Image Guidance, Intrafraction Kolovoltage X-ray Imaging
- What is being tested?
- Markerless Tumour Tracking
- Type of treatment
- Surgery or procedure
- How many people
- 5 participants
- Where
- 1 siteAustralia
- Study dates
- 4 Dec 2020to 31 Dec 2027
- Phase
- Observational
- 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 to 80 years
- All sexes
- Adult, Older adult
Study population: Adults >=18 years with NSCLC
Who may be able to join
- Aged 18 or older.
- Has provided written Informed Consent for participation in this trial and is willing to comply with the study.
- Patients undergoing external beam radiotherapy.
- Histologically proven Stage I NSCLC or oligometastatic lung metastases (3 or less).
- Diagnostic 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).
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- 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 <=8 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, concurrently with treatment or 7 days after radiotherapy.
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- Women who are pregnant or lactating.
- Unwilling or unable to give informed consent.
- Unwilling or unable to complete quality of life questionnaires.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Royal North Shore Hospital
Saint Leonards, New South Wales, 2065
About this study
Official title: Validation of Markerless Image Guidance Using Intrafraction Kolovoltage X-ray Imaging Using Implanted Fiducials: Phase I Observational Study of Lung Cancer Radiotherapy
In radiotherapy, tumour tracking allows us to ensure the radiation beam is accurately targeting the tumour while it moves in a complex and unpredictable way. Most tumour tracking techniques require the implantation of fiducial markers around the tumour. Markerless Tumour Tracking negates the need for implanted markers, enabling accurate and optimal cancer radiotherapy in a non-invasive way.
Read the detailed description
We will perform a phase I observational trial investigating the feasibility of the Markerless Tumour Tracking technology. Markerless Tumour Tracking will be integrated with existing treatment machines to provide real-time monitoring of tumour motion during treatment delivery. Eligible patients are 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 and used to calculate online Markerless Tumour Tracking. Markerless Tumour Tracking determines the mean tumour position calculated over the most recent 15 seconds and displays shifts exceeding 3 mm.
The trial will be a single-institution study recruiting only at RNSH Radiation Oncology Department.
As this trial investigates feasibility, our focus will be on estimating the proportion of treatment time in which the Markerless Tumour Tracking is within acceptable limits.
- Being tested
- Markerless Tumour Tracking
- Keywords
- Lung Cancer, Radiotherapy, Fiducials, Markerless Tumour Tracking
- 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 Tumour TrackingRadiation
Intrafraction Kolovoltage X-ray Imaging using Fiducials
| Study group | Role | What they receive |
|---|---|---|
| Markerless | Markerless Tumour Tracking will be used to observe the radiation beam is accurately targeting the tumour. Receives: Radiation: Markerless Tumour Tracking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Markerless Tumour Tracking
to demonstrate the feasibility of Markerless Tumour Tracking for motion-adaptive lung cancer radiotherapy as assessed by agreement between markerless and marker-based tracking within 3 mm for at least 80% of the beam-on time as assessed in off-line analyses.
Measured: 6 months after recruitment
Secondary outcomes (12)
Markerless Tumour Tracking outcome
To identify cohort of patients on which markerless Tumour tracking performs well or poorly
Measured: 6 months after treatment of last fraction
Accuracy
To quantify the accuracy of marker-based tracking by comparison with MV-kV triangulation or visual inspection
Measured: 6 months after treatment of last fraction
Magnitude
To investigate the magnitude of surrogacy of lung tumour motion, ie the difference between tumour motion and implanted marker motion
Measured: 6 months after treatment of last fraction
Correlation
To investigate the correlation between external and internal motion using infrared/optical imaging
Measured: 6 months after treatment of last fraction
Suitability
To investigate the suitability and frequency of correcting for tumour baseline shifts based on a variety of tolerance criteria and with different methods
Measured: 6 months after treatment of last fraction
Frequency
To investigate the frequency of correcting for tumour baseline shifts based on a variety of tolerance criteria and with different methods
Measured: 6 months after treatment of last fraction
Feasibility of outcomes prediction
To investigate the feasibility of predicting treatment outcomes based on patient and imaging information
Measured: 6 months after treatment of last fraction
Outcomes
Participants will be followed for 2 years to determine patient outcomes, including radiation therapy toxicity, local control (whether the tumour has spread) and survival
Measured: 6 months after treatment of last fraction
Historical
2 year outcomes will be compared to historical outcomes reported from our lung Departmental SBRT database
Measured: 6 months after treatment of last fraction
Ineligibility
To record the number of patients ineligible after marker insertion due to positioning of markers, or due to complications with the implantation procedure
Measured: 6 months after treatment of last fraction
Radiomic Features
To investigate the feasibility of extracting radiomic features from CT, CBCT, and kV images to predict tumour volumes, tracking accuracy, treatment response, and patient outcomes.
Measured: 6 months after treatment of last fraction
X-ray dose
To report additional x-ray dose caused by imaging during treatment
Measured: 6 months after treatment of last fraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start4 Dec 2020
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal North Shore Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sydney
- Responsible party
- Principal investigator, Dasantha Jayamanne, Royal North Shore Hospital
- Investigators
- Dasantha Jayamanne, MD, Principal investigator, Royal North Shore Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04310891
- Sponsor's protocol ID
- VALKIM
- Acronym
- VALKIM
- Status last verified
- Jan 2026
- First submitted
- 12 Mar 2020
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Markerless Image Guidance Using Intrafraction Kolovoltage X-ray Imaging Using Implanted Fiducials: Phase I Observational Study of Lung Cancer Radiotherapy
- ClinicalTrials.gov ID
- NCT04310891
- Acronym / sponsor ID
- VALKIM / VALKIM
- Keywords
- Lung Cancer, Radiotherapy, Fiducials, Markerless Tumour Tracking
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Royal North Shore HospitalUniversity, hospital or other
- Collaborators
- University of Sydney
- Study start
- 4 Dec 2020 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Mar 2020 (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.
In radiotherapy, tumour tracking allows us to ensure the radiation beam is accurately targeting the tumour while it moves in a complex and unpredictable way. Most tumour tracking techniques require the implantation of fiducial markers around the tumour. Markerless Tumour Tracking negates the need for implanted markers, enabling accurate and optimal cancer radiotherapy in a non-invasive way.
Detailed description
We will perform a phase I observational trial investigating the feasibility of the Markerless Tumour Tracking technology. Markerless Tumour Tracking will be integrated with existing treatment machines to provide real-time monitoring of tumour motion during treatment delivery. Eligible patients are 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 and used to calculate online Markerless Tumour Tracking. Markerless Tumour Tracking determines the mean tumour position calculated over the most recent 15 seconds and displays shifts exceeding 3 mm.
The trial will be a single-institution study recruiting only at RNSH Radiation Oncology Department.
As this trial investigates feasibility, our focus will be on estimating the proportion of treatment time in which the Markerless Tumour Tracking is within acceptable limits.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Markerless | – | Radiation: Markerless Tumour TrackingMarkerless Tumour Tracking will be used to observe the radiation beam is accurately targeting the tumour. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adults >=18 years with NSCLC
Key inclusion criteria (10 listed)
- Aged 18 or older.
- Has provided written Informed Consent for participation in this trial and is willing to comply with the study.
- Patients undergoing external beam radiotherapy.
- Histologically proven Stage I NSCLC or oligometastatic lung metastases (3 or less).
- Diagnostic CT prior to insertion of fiducial markers.
Key exclusion criteria (9 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 Tumour TrackingIntrafraction Kolovoltage X-ray Imaging using Fiducials | Radiation | Markerless |
Primary outcome
Markerless Tumour Tracking
Time frame: 6 months after recruitment
to demonstrate the feasibility of Markerless Tumour Tracking for motion-adaptive lung cancer radiotherapy as assessed by agreement between markerless and marker-based tracking within 3 mm for at least 80% of the beam-on time as assessed in off-line analyses.
12 secondary outcomes
Markerless Tumour Tracking outcome
Time frame: 6 months after treatment of last fraction
Accuracy
Time frame: 6 months after treatment of last fraction
Magnitude
Time frame: 6 months after treatment of last fraction
Correlation
Time frame: 6 months after treatment of last fraction
Suitability
Time frame: 6 months after treatment of last fraction
Frequency
Time frame: 6 months after treatment of last fraction
Feasibility of outcomes prediction
Time frame: 6 months after treatment of last fraction
Outcomes
Time frame: 6 months after treatment of last fraction
Historical
Time frame: 6 months after treatment of last fraction
Ineligibility
Time frame: 6 months after treatment of last fraction
Radiomic Features
Time frame: 6 months after treatment of last fraction
X-ray dose
Time frame: 6 months after treatment of last fraction
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 29 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Dasantha Jayamanne, MD principal investigator
Royal North Shore Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Markerless Image Guidance, run by Royal North Shore Hospital 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 10 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 29 Jan 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Markerless Tumour Tracking (time frame: 6 months after recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jan 2026.