Radio-opaque Contrast Agents for Liver Cancer Targeting With KIM During Radiation Therapy
ConditionLiver Neoplasm
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Sydney
About this trial
This observational study will investigate the properties of image files standardly collected during radiation therapy treatment in a cross-section of liver cancer patients who received stereotactic ablative body radiation therapy (SABR) after trans-catheter arterial chemo emobilisation (TACE). Specifically, it will determine whether the radio-opaque contrast agents in the image files can be detected by tumour-tracking software (KIM).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Received or will receive stereotactic ablative body radiotherapy (SABR) treatment for liver cancer at a participating site.
Received a radio-opaque contrast agent (e.g. Lipiodol™ or DC Bead LUMI™) that is visible on the radiation treatment planning CT scan
The radio-opaque contrast agent mass is or will be within the x-ray imaging field of view during the CBCT scan and any planned intra-fraction imaging. Note that there is no requirement of the distance between the contrast agent mass and the treated tumour as the goal of the study is the contrast agent mass tracking.
Provides written informed consent (prospectively recruited) or meets criteria for waiving of the requirement for consent (retrospectively recruited)
Disqualifiers
Less than 18 years of age
Minimum image dataset is not available
Image dataset is not in a compatible format
Trial population
Patients who had or will have SABR for liver cancer following TACE chemotherapy.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Proportion of images that have contrast mass detection by software
Proportion of images in which kilovoltage intrafraction monitoring software detects contrast agent mass on CBCT and intra-treatment images
Time frame
2 weeks2
Average difference between software and ground truth measure
Average difference (mm) of location of contrast mass detection on CBCT and treatment images by KIM software compared to the ground truth in each of the horizontal and vertical directions.
Time frame
2 weeks3
Standard deviation of difference between software and ground truth measure
Standard deviation difference (mm) of location of contrast mass detection on CBCT and treatment images by KIM software compared to the ground truth in each of the horizontal and vertical directions.
Time frame
2 weeksSecondary outcomes
1
Modelling of patient or treatment features that contributed to the success or failure of the KIM method
Using the KIM success rate (primary hypothesis) and patient CT imaging features (contrast agent density, size, shape and location, patient size etc) a generalised linear model, or appropriate alternative, will be used to identity univariate and multivariate patient or treatment features that contributed to the success or failure of the KIM method. Selected features will be identified and developed into a model. If the model predicts the likelihood of KIM success in at least 85% of the patients then the study will be deemed to have achieved the hypothesis.
Time frame
2 weeksSponsors and contacts
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University of Sydney
Lead sponsor
Calvary Mater Newcastle, Australia
Collaborator
Western Sydney Local Health District
Collaborator
Austin Health
Collaborator
Peter MacCallum Cancer Centre, Australia
Collaborator
Princess Alexandra Hospital, Brisbane, Australia
Collaborator
Source ClinicalTrials.gov