Liver NeoplasmROCK-RTNCT05169177
Radio-opaque Contrast Agents for Liver Cancer Targeting With KIM During Radiation Therapy
An observational study of Liver Neoplasm, run by University of Sydney at 5 sites in Australia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Neoplasm
- How many people
- 50 participants
- Where
- 5 sitesAustralia
- Study dates
- 17 Oct 2022to 31 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who had or will have SABR for liver cancer following TACE chemotherapy.
Who may be able to join
- 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)
Who cannot join
- Less than 18 years of age
- Minimum image dataset is not available
- Image dataset is not in a compatible format
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Australia5 sites, 5 recruiting
- Not yet recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Principal Investigator, Richard.Khor@austin.org.au
- Not yet recruiting
The Austin Hospital
Melbourne, Victoria, 3000
Principal Investigator, Nick.Hardcastle@petermac.org
- Not yet recruiting
Calvary Mater Newcastle Hospital
Waratah, New South Wales, 2298
Principal Investigator, Jarad.Martin@calvarymater.org.au
- Not yet recruiting
Westmead Hospital
Westmead, New South Wales, 2145
Principal Investigator, Tim.Wang2@health.nsw.gov.au
- Recruiting
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Principal Investigator, David.Pryor@health.qld.gov.au
About this study
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).
Read the 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.
- Conditions
- Liver Neoplasm
- Keywords
- Radiation Therapy, Stereotactic Ablative Body Radiation Therapy, SABR, Kilovoltage intrafraction monitoring, Radio opaque contrast
- Medical subject headings
- Liver Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of images that have contrast mass detection by software
Proportion of images in which kilovoltage intrafraction monitoring software detects contrast agent mass on CBCT and intra-treatment images
Measured: 2 weeks
Average difference between software and ground truth measure
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.
Measured: 2 weeks
Standard deviation of difference between software and ground truth measure
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.
Measured: 2 weeks
Secondary outcomes (1)
Modelling of patient or treatment features that contributed to the success or failure of the KIM method
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2021
- Study start17 Oct 2022
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sydney
- Sponsor type
- University, hospital or other
- Collaborators
- Calvary Mater Newcastle, Australia, Western Sydney Local Health District, Austin Health, Peter MacCallum Cancer Centre, Australia, Princess Alexandra Hospital, Brisbane, Australia
- Responsible party
- Sponsor
- Investigators
- Paul Keall, PhD, Study chair, University of Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05169177
- Sponsor's protocol ID
- IX-2020-DS-ROCKRT
- Acronym
- ROCK-RT
- Status last verified
- May 2026
- First submitted
- 8 Dec 2021
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 39380004
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radio-opaque Contrast Agents for Liver Cancer Targeting With KIM During Radiation Therapy
- ClinicalTrials.gov ID
- NCT05169177
- Acronym / sponsor ID
- ROCK-RT / IX-2020-DS-ROCKRT
- Conditions
- Liver Neoplasm
- Keywords
- Radiation Therapy, Stereotactic Ablative Body Radiation Therapy, SABR, Kilovoltage intrafraction monitoring, Radio opaque contrast
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of SydneyUniversity, hospital or other
- Collaborators
- Calvary Mater Newcastle, Australia, Western Sydney Local Health District, Austin Health, Peter MacCallum Cancer Centre, Australia, Princess Alexandra Hospital, Brisbane, Australia
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 23 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who had or will have SABR for liver cancer following TACE chemotherapy.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- Less than 18 years of age
- Minimum image dataset is not available
- Image dataset is not in a compatible format
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
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.
1 secondary outcome
Modelling of patient or treatment features that contributed to the success or failure of the KIM method
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Derived from this study: PubMed 39380004Plant 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul Keall, PhD study chair
University of Sydney
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Neoplasm, run by University of Sydney at 5 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shona Silvester (+61 2 8627 1185, Shona.Silvester@sydney.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of images that have contrast mass detection by software (time frame: 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05169177, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.