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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/NCT05169177
Registration number
NCT05169177
Ethics application status
Date submitted
8/12/2021
Date registered
23/12/2021
Date last updated
22/06/2023
Titles & IDs
Public title
Radio-opaque Contrast Agents for Liver Cancer Targeting With KIM During Radiation Therapy
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Scientific title
Radio-opaque Contrast Agents for Liver Cancer Targeting With KIM During Radiation Therapy
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Secondary ID [1]
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IX-2020-DS-ROCKRT
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Universal Trial Number (UTN)
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Trial acronym
ROCK-RT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Liver Neoplasm
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Condition category
Condition code
Cancer
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Liver
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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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
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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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Proportion of images that have contrast mass detection by software
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Assessment method [1]
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Proportion of images in which kilovoltage intrafraction monitoring software detects contrast agent mass on CBCT and intra-treatment images
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Timepoint [1]
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2 weeks
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Primary outcome [2]
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Average difference between software and ground truth measure
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Assessment method [2]
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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.
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Timepoint [2]
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2 weeks
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Primary outcome [3]
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Standard deviation of difference between software and ground truth measure
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Assessment method [3]
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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.
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Timepoint [3]
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2 weeks
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Secondary outcome [1]
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Modelling of patient or treatment features that contributed to the success or failure of the KIM method
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Assessment method [1]
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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.
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Timepoint [1]
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2 weeks
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Eligibility
Key inclusion criteria
- 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)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Less than 18 years of age
- Minimum image dataset is not available
- Image dataset is not in a compatible format
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Study design
Purpose
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Duration
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Selection
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Timing
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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
17/10/2022
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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
31/10/2026
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Actual
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Sample size
Target
50
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Calvary Mater Newcastle Hospital - Waratah
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Recruitment hospital [2]
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Westmead Hospital - Westmead
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Recruitment hospital [3]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [4]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [5]
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The Austin Hospital - Melbourne
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Recruitment postcode(s) [1]
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2298 - Waratah
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Recruitment postcode(s) [2]
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2145 - Westmead
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Recruitment postcode(s) [3]
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4102 - Woolloongabba
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Recruitment postcode(s) [4]
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3000 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Sydney
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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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Calvary Mater Newcastle, Australia
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Western Sydney Local Health District
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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Austin Health
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Address [3]
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Country [3]
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Other collaborator category [4]
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Other
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Name [4]
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Peter MacCallum Cancer Centre, Australia
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Address [4]
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Country [4]
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Other collaborator category [5]
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Other
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Name [5]
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Princess Alexandra Hospital, Brisbane, Australia
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Address [5]
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Country [5]
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Ethics approval
Ethics application status
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Summary
Brief summary
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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05169177
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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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Paul Keall, PhD
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Address
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University of Sydney
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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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Shona Silvester
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Address
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Country
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Phone
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+61 2 8627 1185
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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/NCT05169177
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