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All patients will receive liver SABR. Kilovoltage Intrafraction Monitoring (KIM) tracking will be trialed during mock treatment. If KIM is successful, it will be used throughout treatment. If unsuccessful, cone beam CT will be used instead.

KIM is a novel intrafraction real-time tumour localization method. It involves a single gantry-mounted kV x-ray imager acquiring 2D projections of implanted fiducial markers. 3D positions are then reconstructed by maximum likelihood estimation of a 3D probability density function.

Kilovoltage Intrafraction Monitoring

Tim Wang, Dr

Primary and secondary liver cancer patients will receive liver SABR with or without KIM intervention.

This is a single arm, phase II, two stage study designed to evaluate cancer targeting accuracy, treatment outcomes and treatment efficiency in 46 patients eligible for SABR for either primary or secondary liver malignancy with the incorporation of KIM.

Liver Ablative Radiotherapy Utilising Kilovoltage Intrafraction Monitoring (KIM)

LARK: Liver Ablative Radiotherapy Utilising Kilovoltage Intrafraction Monitoring (KIM)

Anonymised data will be made available to researchers upon request, once evidence of ethical approval has been provided.

Isodose distributions and dose volume histograms for each session will be calculated with KIM corrections as treated, and estimated without KIM corrections. The planning CT scan will be used for this assessment

The time taken for the KIM treatments compared with the time taken for similar treatments from previous patients, accounting for the difference in the time and number of patient images acquired and the time taken to adjust the patient's position during treatment

The KIM procedure adds radiation dose with the kilovoltage images. However, there may be fewer volumetric cone beam computed tomography (CBCT) scans acquired. This difference in dose will be estimated and analysed

The clinical target volume (CTV) to planning target volume (PTV) margin with and without KIM will be recorded and analysed.

Isodose distributions and dose volume histograms for each session will be calculated with KIM corrections as treated, and estimated without KIM corrections. The intratreatment CBCT scans will be used for this assessment.

Difference between dose delivered using KIM with or without MLC tracking

Proportion of local failures at two years for patients treated as assessed using modified RECIST criteria

The proportion of grade 3 or higher toxicities, assessed using CTCAE v4.03

To compare change in Quality of Life, as defined by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30 (Version 3)) from baseline at completion of radiation therapy and at 6 weeks, 3, 6, 12, 18 and 24 months post-radiation therapy. The EORTC QLQ-C30 (Version 3) uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome. The EORTC QLQ-C30 (Version 3) uses for the questions 29 and 30 a 7-points scale. The scale scores from 1 to 7: 1 ("very poor") to 7 ("excellent"). The questionnaire will be self-administered and will be given in patient's mother tongue.

To compare change in Quality of Life related to hepatocellular carcinoma (HCC) as defined by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Hepatocellular Carcinoma 18 Module (EORTC QLQ-HCC) from baseline at completion of radiation therapy and at 6 weeks, 3, 6, 12 and 18 months post-radiation therapy. The questionnaire will be self-administered and will be given to patients proficient in English. EORTC-QLQ-HCC18: includes HCC-specific symptoms or problems. Questions used 4-point Likert scale from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems.

University of Sydney

Shona Silvester

Natalie Plant

Principal Investigator

Paul Keall, PhD

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).

* 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.

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

After study completion, de-identified (non-coded, non-re-identifiable) data may be shared with researchers for further scientific research. Information about data sharing will be provided to study participants in the Patient Information Sheet.

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

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 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.

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 title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Liver Ablative Radiotherapy Utilising Kilovoltage Intrafraction Monitoring (KIM)	NCT02984566	Liver Cancer	Kilovoltage Int...	18 Years - 85 Years	University of Sydney
Radio-opaque Contrast Agents for Liver Cancer Targeting With KIM During Radiation Therapy	NCT05169177	Liver Neoplasm		18 Years -	University of Sydney

Spots Global Cancer Trial Database for kilovoltage intrafraction monitoring