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

NCT ID: NCT05169177

Last Updated: 2024-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-17

Study Completion Date

2026-10-31

Brief Summary

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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

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* 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

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Liver Neoplasm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Calvary Mater Newcastle, Australia

OTHER

Sponsor Role collaborator

Western Sydney Local Health District

OTHER

Sponsor Role collaborator

Austin Health

OTHER_GOV

Sponsor Role collaborator

Peter MacCallum Cancer Centre, Australia

OTHER

Sponsor Role collaborator

Princess Alexandra Hospital, Brisbane, Australia

OTHER

Sponsor Role collaborator

University of Sydney

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul Keall, PhD

Role: STUDY_CHAIR

University of Sydney

Locations

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Calvary Mater Newcastle Hospital

Waratah, New South Wales, Australia

Site Status NOT_YET_RECRUITING

Westmead Hospital

Westmead, New South Wales, Australia

Site Status NOT_YET_RECRUITING

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Site Status RECRUITING

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Site Status NOT_YET_RECRUITING

The Austin Hospital

Melbourne, Victoria, Australia

Site Status NOT_YET_RECRUITING

Countries

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Australia

Central Contacts

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Shona Silvester

Role: CONTACT

+61 2 8627 1185

Facility Contacts

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Principal Investigator

Role: primary

Principal Investigator

Role: primary

Principal Investigator

Role: primary

Principal Investigator

Role: primary

Principal Investigator

Role: primary

References

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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.

Reference Type DERIVED
PMID: 39380004 (View on PubMed)

Other Identifiers

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IX-2020-DS-ROCKRT

Identifier Type: -

Identifier Source: org_study_id

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