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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04310891




Registration number
NCT04310891
Ethics application status
Date submitted
12/03/2020
Date registered
17/03/2020

Titles & IDs
Public title
Markerless Image Guidance Using Intrafraction Kolovoltage X-ray Imaging for Lung Cancer Radiotherapy
Scientific title
Validation of Markerless Image Guidance Using Intrafraction Kolovoltage X-ray Imaging Using Implanted Fiducials: Phase I Observational Study of Lung Cancer Radiotherapy
Secondary ID [1] 0 0
VALKIM
Universal Trial Number (UTN)
Trial acronym
VALKIM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Cancer 0 0
Markerless Image Guidance 0 0
Intrafraction Kolovoltage X-ray Imaging 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Markerless Tumour Tracking
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
6 months after recruitment
Secondary outcome [1] 0 0
Markerless Tumour Tracking outcome
Assessment method [1] 0 0
To identify cohort of patients on which markerless Tumour tracking performs well or poorly
Timepoint [1] 0 0
6 months after treatment of last fraction
Secondary outcome [2] 0 0
Accuracy
Assessment method [2] 0 0
To quantify the accuracy of marker-based tracking by comparison with MV-kV triangulation or visual inspection
Timepoint [2] 0 0
6 months after treatment of last fraction
Secondary outcome [3] 0 0
Magnitude
Assessment method [3] 0 0
To investigate the magnitude of surrogacy of lung tumour motion, ie the difference between tumour motion and implanted marker motion
Timepoint [3] 0 0
6 months after treatment of last fraction
Secondary outcome [4] 0 0
Correlation
Assessment method [4] 0 0
To investigate the correlation between external and internal motion using infrared/optical imaging
Timepoint [4] 0 0
6 months after treatment of last fraction
Secondary outcome [5] 0 0
Suitability
Assessment method [5] 0 0
To investigate the suitability and frequency of correcting for tumour baseline shifts based on a variety of tolerance criteria and with different methods
Timepoint [5] 0 0
6 months after treatment of last fraction
Secondary outcome [6] 0 0
Frequency
Assessment method [6] 0 0
To investigate the frequency of correcting for tumour baseline shifts based on a variety of tolerance criteria and with different methods
Timepoint [6] 0 0
6 months after treatment of last fraction
Secondary outcome [7] 0 0
Feasibility of outcomes prediction
Assessment method [7] 0 0
To investigate the feasibility of predicting treatment outcomes based on patient and imaging information
Timepoint [7] 0 0
6 months after treatment of last fraction
Secondary outcome [8] 0 0
Outcomes
Assessment method [8] 0 0
Participants will be followed for 2 years to determine patient outcomes, including radiation therapy toxicity, local control (whether the tumour has spread) and survival
Timepoint [8] 0 0
6 months after treatment of last fraction
Secondary outcome [9] 0 0
Historical
Assessment method [9] 0 0
2 year outcomes will be compared to historical outcomes reported from our lung Departmental SBRT database
Timepoint [9] 0 0
6 months after treatment of last fraction
Secondary outcome [10] 0 0
Ineligibility
Assessment method [10] 0 0
To record the number of patients ineligible after marker insertion due to positioning of markers, or due to complications with the implantation procedure
Timepoint [10] 0 0
6 months after treatment of last fraction
Secondary outcome [11] 0 0
Radiomic Features
Assessment method [11] 0 0
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.
Timepoint [11] 0 0
6 months after treatment of last fraction
Secondary outcome [12] 0 0
X-ray dose
Assessment method [12] 0 0
To report additional x-ray dose caused by imaging during treatment
Timepoint [12] 0 0
6 months after treatment of last fraction

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.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal North Shore Hospital - Saint Leonards
Recruitment postcode(s) [1] 0 0
2065 - Saint Leonards

Funding & Sponsors
Primary sponsor type
Other
Name
Royal North Shore Hospital
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Sydney
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Dasantha Jayamanne, MD
Address 0 0
Royal North Shore Hospital
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Carol Kwong, RN
Address 0 0
Country 0 0
Phone 0 0
+61294631339
Email 0 0
carolyn.kwong@health.nsw.gov.au
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04310891