ROCK-RT: Radio-opaque Contrast Agents for Liver Cancer Targeting With KIM During Radiation Therapy: An Observational Feasibility Study

Sponsor

University of Sydney (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05169177

Collaborator

Calvary Mater Newcastle, Australia (Other), Western Sydney Local Health District (Other), Austin Health (Other), Peter MacCallum Cancer Centre, Australia (Other), Princess Alexandra Hospital, Brisbane, Australia (Other)

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Liver Neoplasm

Detailed Description

Sites will collect image files from the Cancer Radiation Therapy Systems and the medical records of eligible participants. For patient who do not have implanted markers, research personnel (a radiation oncologist, medical physicist or radiation therapist) will manually outline the visible contrast mass. This outline is considered the 'ground truth' of the location of the contrast mass. To ensure its accuracy, the ground truth contrast mass location will be checked by research personnel from another study site.
Image and ground truth data collected from 80% of participants will be used by University of Sydney researchers to develop the KIM algorithm to detect and track the radio-opaque contrast agents with sufficient robustness to provide justification for the prospective use of KIM as a real-time image guided radiation therapy tool for liver cancer patients.
The developed KIM software will be applied by site Medical Physicist(s) to the treatment imaging data from the remaining 20% of participants the images. Tumour positions produced by KIM will be compared with a 'ground truth' manual delineation.

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

Radio-opaque Contrast Agents for Liver Cancer Targeting With KIM During Radiation Therapy: An Observational Feasibility Study

Anticipated Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Jan 31, 2024

Anticipated Study Completion Date :

Jan 31, 2026

Outcome Measures

Primary Outcome Measures

Contrast mass detection by software [2 weeks]
Kilovoltage intrafraction monitoring software detects contrast agent mass on CBCT and intra-treatment images
Average difference between software and ground truth measure [2 weeks]
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.
Standard deviation of difference between software and ground truth measure [2 weeks]
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.

Secondary Outcome Measures

Modelling of patient or treatment features that contributed to the success or failure of the KIM method [2 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Exclusion Criteria:

Less than 18 years of age
Minimum image dataset is not available
Image dataset is not in a compatible format

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Calvary Mater Newcastle Hospital	Waratah	New South Wales	Australia	2298
2	Westmead Hospital	Westmead	New South Wales	Australia	2145
3	Princess Alexandra Hospital	Woolloongabba	Queensland	Australia	4102
4	Peter MacCallum Cancer Centre	Melbourne	Victoria	Australia	3000
5	The Austin Hospital	Melbourne	Victoria	Australia	3000