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

NCT05169177 | Recruiting

• 1 other identifier: IX-2020-DS-ROCKRT
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 5

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).

Conditions

Liver Neoplasm

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  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.

  2 weeks

Secondary Outcomes (1)

• Modelling of patient or treatment features that contributed to the success or failure of the KIM method

  2 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who had or will have SABR for liver cancer following TACE chemotherapy.

You may qualify if:

• 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)

You may not qualify if:

• Less than 18 years of age
• Minimum image dataset is not available
• Image dataset is not in a compatible format

Sponsors & Collaborators

• University of Sydney: lead
• Calvary Mater Newcastle, Australia: collaborator
• Western Sydney Local Health District: collaborator
• Austin Health: collaborator
• Peter MacCallum Cancer Centre, Australia: collaborator
• Princess Alexandra Hospital, Brisbane, Australia: collaborator

Study Sites (5)

Calvary Mater Newcastle Hospital

Waratah, New South Wales, 2298, Australia

NOT YET RECRUITING

Westmead Hospital

Westmead, New South Wales, 2145, Australia

NOT YET RECRUITING

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

RECRUITING

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

NOT YET RECRUITING

The Austin Hospital

Melbourne, Victoria, 3000, Australia

NOT YET RECRUITING

Related Publications (1)

• 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.

  PMID: 39380004 DERIVED

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• Paul Keall, PhD

  University of Sydney

  STUDY CHAIR

Central Study Contacts

Shona Silvester

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: December 23, 2021
• Study Start: October 17, 2022
• Primary Completion: October 31, 2024
• Study Completion (Estimated): October 31, 2026
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After study analyses and publications are complete.
• Access Criteria: Data stored at the university: In order to download / decompress the stored, de-identified data, participating researchers will agree to the terms of use for the data, including: (i) that the data are not to be published or otherwise redistributed without the express consent of the original investigator(s) and (ii) that the data are forbidden to be used for any commercial purpose. Data stored at an external repository: de-identified study data may be provided to an eternal research data repository, archive or register so that it may be made publicly available for other scientific research. Study data that are provided to an external research data repository will be stored at and managed by the external repository. Data will only be shared with repositories whose function has been reviewed and approved by an accredited Research Integrity/Ethics Committee/Board, under a Materials Transfer Agreement with the university.

Locations

AU (5)