Liver Ablative Radiotherapy Utilising Kilovoltage Intrafraction Monitoring (KIM) (LARK)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02984566|
Recruitment Status : Not yet recruiting
First Posted : December 7, 2016
Last Update Posted : September 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Liver Cancer||Device: Kilovoltage Intrafraction Monitoring||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||LARK: Liver Ablative Radiotherapy Utilising Kilovoltage Intrafraction Monitoring (KIM)|
|Estimated Study Start Date :||October 2019|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||March 2021|
Experimental: SABR with or without KIM
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.
Device: Kilovoltage Intrafraction Monitoring
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.
- Quantify accumulated patient dose distribution with the KIM intervention compared to dose distribution estimated without the KIM intervention. [ Time Frame: 2 years ]
- Quantitative assessment of treatment time. [ Time Frame: 2 years ]
- Quantitative assessment of imaging dose. [ Time Frame: 2 years ]
- Quantitative assessment of PTV margins. [ Time Frame: 2 years ]
- Quantitative assessment of cone-beam CT dose reconstruction. [ Time Frame: 2 years ]
- Quantitative assessment of dose reduction with MLC tracking [ Time Frame: 2 years ]
- Patient treatment outcome [ Time Frame: 2 years ]Determined by assessing local failure (as per modified RECIST criteria).
- Patient treatment outcome [ Time Frame: 30 days and 2 years ]Determined by assessing acute and late toxicity grade 3 or higher (as per CTCAE v4.03).
- Patient treatment outcome [ Time Frame: 4-6 weeks and 4, 8, 12, 18, and 24 months after treatment ]Determined by reviewing patient-reported outcomes on completion of radiation therapy, and at set time points after treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02984566
|Contact: Doan Nguyen, PhD||+61 2 8627 firstname.lastname@example.org|
|Contact: Shona Silvester, Mastersemail@example.com|
|Principal Investigator:||Tim Wang, Dr||Westmead Hospital|