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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05169177

Acronym

ROCK-RT

Enrollment

Registered

2021-12-23

Start date

2022-10-17

Completion date

2026-10-31

Last updated

2026-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Neoplasm

Keywords

Radiation Therapy, Stereotactic Ablative Body Radiation Therapy, SABR, Kilovoltage intrafraction monitoring, Radio opaque contrast

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).

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Proportion of images that have contrast mass detection by software	2 weeks	Proportion of images in which 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

Measure	Time frame	Description
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.

Countries

Australia

Contacts

CONTACTShona Silvester

Shona.Silvester@sydney.edu.au+61 2 8627 1185

STUDY_CHAIRPaul Keall, PhD

University of Sydney

Outcome results