Radio-opaque Contrast Agents for Liver Cancer Targeting With KIM During Radiation Therapy

Overview

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).

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.

Primary outcome measures

• Proportion of images that have contrast mass detection by software [Time frame: 2 weeks]
• Average difference between software and ground truth measure [Time frame: 2 weeks]
• Standard deviation of difference between software and ground truth measure [Time frame: 2 weeks]

Secondary outcome measures (1)

• Modelling of patient or treatment features that contributed to the success or failure of the KIM method [Time frame: 2 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Australia · 5 centers

• Calvary Mater Newcastle Hospital — Waratah
• Westmead Hospital — Westmead
• Princess Alexandra Hospital — Woolloongabba
• Peter MacCallum Cancer Centre — Melbourne
• The Austin Hospital — Melbourne

Publications

• Plant N, Mylonas A, Sengupta C, Nguyen DT, Silvester S, Pryor D, Greer P, Lee YYD, Ramachandran P, Seshadri V, Trada Y, Khor R, Wang T, Hardcastle N, Keall P. Radio-opaque contrast agents for liver cancer targeting with KIM during radiation therapy (ROCK-RT): an observational feasibility study. Radiat Oncol. 2024 Oct 8;19(1):139. doi: 10.1186/s13014-024-02524-4. PMID 39380004

Identifiers

NCT: NCT05169177 · IX-2020-DS-ROCKRT

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗