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NCT Number: NCT05169177

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

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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Key information

Conditions

Liver Neoplasm Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Calvary Mater Newcastle Hospital, Waratah, New South Wales, Australia

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About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Proportion of images that have contrast mass detection by software

    Time frame: 2 weeks

    Proportion of images in which kilovoltage intrafraction monitoring software detects contrast agent mass on CBCT and intra-treatment images

  2. Average difference between software and ground truth measure

    Time frame: 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.

  3. Standard deviation of difference between software and ground truth measure

    Time frame: 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 outcomes

  1. Modelling of patient or treatment features that contributed to the success or failure of the KIM method

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Shona Silvester

CONTACT

[email protected]

+61 2 8627 1185

Sponsors and collaborators

Lead sponsor

University of Sydney

Other

Collaborators

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

Registry information

Acronym: ROCK-RT

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Dec 23, 2021
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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