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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04310891
Registration number
NCT04310891
Ethics application status
Date submitted
12/03/2020
Date registered
17/03/2020
Date last updated
18/11/2023
Titles & IDs
Public title
Markerless Image Guidance Using Intrafraction Kolovoltage X-ray Imaging for Lung Cancer Radiotherapy
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Scientific title
Validation of Markerless Image Guidance Using Intrafraction Kolovoltage X-ray Imaging Using Implanted Fiducials: Phase I Observational Study of Lung Cancer Radiotherapy
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Secondary ID [1]
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VALKIM
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Universal Trial Number (UTN)
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Trial acronym
VALKIM
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Lung Cancer
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Markerless Image Guidance
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Intrafraction Kolovoltage X-ray Imaging
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Other - Markerless Tumour Tracking
Markerless - Markerless Tumour Tracking will be used to observe the radiation beam is accurately targeting the tumour.
Treatment: Other: Markerless Tumour Tracking
Intrafraction Kolovoltage X-ray Imaging using Fiducials
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Markerless Tumour Tracking
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Assessment method [1]
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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.
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Timepoint [1]
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6 months after recruitment
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Secondary outcome [1]
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Markerless Tumour Tracking outcome
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Assessment method [1]
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To identify cohort of patients on which markerless Tumour tracking performs well or poorly
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Timepoint [1]
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6 months after treatment of last fraction
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Secondary outcome [2]
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Accuracy
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Assessment method [2]
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To quantify the accuracy of marker-based tracking by comparison with MV-kV triangulation or visual inspection
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Timepoint [2]
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6 months after treatment of last fraction
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Secondary outcome [3]
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Magnitude
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Assessment method [3]
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To investigate the magnitude of surrogacy of lung tumour motion, ie the difference between tumour motion and implanted marker motion
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Timepoint [3]
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6 months after treatment of last fraction
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Secondary outcome [4]
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Correlation
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Assessment method [4]
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To investigate the correlation between external and internal motion using infrared/optical imaging
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Timepoint [4]
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6 months after treatment of last fraction
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Secondary outcome [5]
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Suitability
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Assessment method [5]
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To investigate the suitability and frequency of correcting for tumour baseline shifts based on a variety of tolerance criteria and with different methods
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Timepoint [5]
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6 months after treatment of last fraction
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Secondary outcome [6]
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Frequency
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Assessment method [6]
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To investigate the frequency of correcting for tumour baseline shifts based on a variety of tolerance criteria and with different methods
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Timepoint [6]
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6 months after treatment of last fraction
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Secondary outcome [7]
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Feasibility of outcomes prediction
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Assessment method [7]
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To investigate the feasibility of predicting treatment outcomes based on patient and imaging information
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Timepoint [7]
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6 months after treatment of last fraction
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Secondary outcome [8]
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Outcomes
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Assessment method [8]
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Participants will be followed for 2 years to determine patient outcomes, including radiation therapy toxicity, local control (whether the tumour has spread) and survival
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Timepoint [8]
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6 months after treatment of last fraction
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Secondary outcome [9]
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Historical
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Assessment method [9]
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2 year outcomes will be compared to historical outcomes reported from our lung Departmental SBRT database
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Timepoint [9]
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6 months after treatment of last fraction
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Secondary outcome [10]
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Ineligibility
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Assessment method [10]
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To record the number of patients ineligible after marker insertion due to positioning of markers, or due to complications with the implantation procedure
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Timepoint [10]
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6 months after treatment of last fraction
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Secondary outcome [11]
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Radiomic Features
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Assessment method [11]
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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.
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Timepoint [11]
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6 months after treatment of last fraction
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Secondary outcome [12]
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X-ray dose
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Assessment method [12]
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To report additional x-ray dose caused by imaging during treatment
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Timepoint [12]
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6 months after treatment of last fraction
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
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Key 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.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
4/12/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2025
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Actual
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Sample size
Target
10
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Royal North Shore Hospital - Saint Leonards
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Recruitment postcode(s) [1]
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2065 - Saint Leonards
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Funding & Sponsors
Primary sponsor type
Other
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Name
Royal North Shore Hospital
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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University of Sydney
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief 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. Markerless Tumour
Tracking negates the need for implanted markers, enabling accurate and optimal cancer
radiotherapy in a non-invasive way.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04310891
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dasantha Jayamanne, MD
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Address
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Royal North Shore Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Carol Kwong, RN
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Address
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Country
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Phone
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+61294631339
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04310891
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