Clinical trial NCT05169177: Radio-opaque Contrast Agents for Liver Cancer Targeting With KIM During Radiation Therapy
Official title: Radio-opaque Contrast Agents for Liver Cancer Targeting With KIM During Radiation Therapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Liver Neoplasm
Keywords: Radiation Therapy
Stereotactic Ablative Body Radiation Therapy
SABR
Kilovoltage intrafraction monitoring
Radio opaque contrast
Lead sponsor: University of Sydney
Sponsor class: OTHER
Collaborators: name: Calvary Mater Newcastle, Australia
name: Western Sydney Local Health District
name: Austin Health
name: Peter MacCallum Cancer Centre, Australia
name: Princess Alexandra Hospital, Brisbane, Australia
First posted: 2021-12-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who had or will have SABR for liver cancer following TACE chemotherapy.

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.

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

Primary outcomes:
measure: Proportion of images that have contrast mass detection by software
timeFrame: 2 weeks
measure: Average difference between software and ground truth measure
timeFrame: 2 weeks
measure: Standard deviation of difference between software and ground truth measure
timeFrame: 2 weeks
Secondary outcomes:
measure: Modelling of patient or treatment features that contributed to the success or failure of the KIM method
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Waratah
country: Australia
facility: Calvary Mater Newcastle Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Melbourne
country: Australia
facility: The Austin Hospital
state: Victoria
Study officials:
affiliation: University of Sydney
name: Paul Keall, PhD
role: STUDY_CHAIR
References: