Liver Ablative Radiotherapy Utilising Kilovoltage Intrafraction Monitoring (KIM)

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-14

Study Completion Date

2026-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Primary and secondary liver cancer patients will receive liver SABR with or without KIM intervention.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT05169177

Liver Neoplasm

RECRUITING

Dynamic Contrast Enhanced HCC SABR Liver Study

NCT02847767

Carcinoma, Hepatocellular

UNKNOWN NA

Stereotactic Radiotherapy and Anti-PD1 Antibody (Pembrolizumab) for Oligometastatic Renal Tumours

NCT02855203

Renal Cell Carcinoma

COMPLETED PHASE1/PHASE2

Standard Versus Radiobiologically-Guided Dose Selected SBRT in Liver Cancer

NCT04745390

Hepatocellular Carcinoma Liver Metastases

RECRUITING NA

Focal Ablative STereotactic Radiosurgery for Cancers of the Kidney

NCT02613819

Renal Cell Carcinoma

UNKNOWN PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a single arm, phase II, two stage study designed to evaluate cancer targeting accuracy, treatment outcomes and treatment efficiency in 46 patients eligible for SABR for either primary or secondary liver malignancy with the incorporation of KIM.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Liver Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Kilovoltage Intrafraction Monitoring

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* ECOG performance status 0-1
* Life expectancy \>6 months
* Number of lesions: ≤ 3
* Lesion size : \< 10 cm for a single lesion (and up to 10 cm cumulative diameter for multiple lesions)
* Child-Pugh A or B7 within 6 weeks prior to study entry
* Unsuitable for RFA or resection or transplant
* Distance from GTV to luminal structures (i.e., oesophagus, stomach, duodenum, small or large bowel) ≥ 10mm
* All blood work obtained within 6 weeks prior to study entry with adequate organ function
* May have had previous surgery, RFA or ethanol injection
* Patient must have been discussed at multidisciplinary tumour board with consensus opinion for SBRT

Exclusion Criteria

* HCC/cholangiocarcinoma with evidence of metastatic disease including nodal or distant metastases
* Metastatic disease with complete liver disease response to first-line chemotherapy (i.e. no target for SBRT)
* Previous radiation to the liver (including SIRTEX)
* Untreated HIV or active hepatitis B/C
* On systemic antineoplastic drug therapy within 7 days before inclusion
* Pregnant or lactating women

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No