Markerless Image Guidance Using Intrafraction Kolovoltage X-ray Imaging for Lung Cancer Radiotherapy (VALKIM)
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|ClinicalTrials.gov Identifier: NCT04310891|
Recruitment Status : Recruiting
First Posted : March 17, 2020
Last Update Posted : June 3, 2021
|Condition or disease||Intervention/treatment|
|Lung Cancer Markerless Image Guidance Intrafraction Kolovoltage X-ray Imaging||Radiation: Markerless Tumour Tracking|
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 Type :||Observational|
|Estimated Enrollment :||10 participants|
|Official Title:||Validation of Markerless Image Guidance Using Intrafraction Kolovoltage X-ray Imaging Using Implanted Fiducials: Phase I Observational Study of Lung Cancer Radiotherapy|
|Actual Study Start Date :||December 4, 2020|
|Estimated Primary Completion Date :||December 31, 2023|
|Estimated Study Completion Date :||December 31, 2023|
Markerless Tumour Tracking will be used to observe the radiation beam is accurately targeting the tumour.
Radiation: Markerless Tumour Tracking
Intrafraction Kolovoltage X-ray Imaging using Fiducials
- 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.
- Markerless Tumour Tracking outcome [ Time Frame: 6 months after treatment of last fraction ]To identify cohort of patients on which markerless Tumour tracking performs well or poorly
- Accuracy [ Time Frame: 6 months after treatment of last fraction ]To quantify the accuracy of marker-based tracking by comparison with MV-kV triangulation or visual inspection
- Magnitude [ Time Frame: 6 months after treatment of last fraction ]To investigate the magnitude of surrogacy of lung tumour motion, ie the difference between tumour motion and implanted marker motion
- Correlation [ Time Frame: 6 months after treatment of last fraction ]To investigate the correlation between external and internal motion using infrared/optical imaging
- Suitability [ Time Frame: 6 months after treatment of last fraction ]To investigate the suitability and frequency of correcting for tumour baseline shifts based on a variety of tolerance criteria and with different methods
- Frequency [ Time Frame: 6 months after treatment of last fraction ]To investigate the frequency of correcting for tumour baseline shifts based on a variety of tolerance criteria and with different methods
- Feasibility of outcomes prediction [ Time Frame: 6 months after treatment of last fraction ]To investigate the feasibility of predicting treatment outcomes based on patient and imaging information
- Outcomes [ Time Frame: 6 months after treatment of last fraction ]Participants will be followed for 2 years to determine patient outcomes, including radiation therapy toxicity, local control (whether the tumour has spread) and survival
- Historical [ Time Frame: 6 months after treatment of last fraction ]2 year outcomes will be compared to historical outcomes reported from our lung Departmental SBRT database
- Ineligibility [ Time Frame: 6 months after treatment of last fraction ]To record the number of patients ineligible after marker insertion due to positioning of markers, or due to complications with the implantation procedure
- Radiomic Features [ Time Frame: 6 months after treatment of last fraction ]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.
- X-ray dose [ Time Frame: 6 months after treatment of last fraction ]To report additional x-ray dose caused by imaging during treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04310891
|Contact: Carol Kwong, RN||+61294631339 ext email@example.com|
|Contact: Heidi Tsang, RN||+61294631340 ext firstname.lastname@example.org|
|Australia, New South Wales|
|Royal North Shore Hospital||Recruiting|
|Saint Leonards, New South Wales, Australia, 2065|
|Contact: Carol Kwong, RN +61 29463 1339 ext 31339 email@example.com|
|Contact: Heidi Tsang, RN +61294631340 ext 31340 firstname.lastname@example.org|
|Principal Investigator: Dasantha Jayamanne, MBBS/FRANZCR|
|Principal Investigator:||Dasantha Jayamanne, MD||Royal North Shore Hospital|