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Multi-target Tracking in Prostate Radiotherapy Using MLC and KIM

Phase I Feasibility Study of Accounting for Relative Motion of Multiple Targets in Prostate Cancer Radiotherapy Using Realtime Multi-leaf Collimator Adaptation and Kilovoltage (kV) Intrafraction Monitoring

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02588846
Acronym
KOALA
Enrollment
0
Registered
2015-10-28
Start date
2024-10-03
Completion date
2024-10-03
Last updated
2024-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Prostate, Radiotherapy, IGRT, VMAT, Image-guided radiation therapy, Volumetric modulated arc therapy, Adaptive radiotherapy

Brief summary

Assessing the feasibility of implementing real-time multi-leaf collimator (MLC) tracking to account for the relative motion of the moving prostate tumour target and the static pelvic nodal target for high-risk prostate cancer patients. The capability of tracking for the relative motion of multiple targets will ensure that all the treatment targets receive correct dose as prescribed by the doctor and minimise side effects to the critical organs.

Detailed description

This study will assess the feasibility of implementing real-time multi-leaf collimator (MLC) tracking to account for the relative motion of the moving prostate tumour target and the static pelvic nodal target for high-risk prostate cancer patients. The capability of tracking for the relative motion of multiple targets will ensure that all the treatment targets receive correct dose as prescribed by the doctor and minimising side effects to the critical organs. During radiation treatment, the prostate position will be monitored in real time using the KIM technology. The nodal target will be imaged before and after each treatment to evaluate the nodal treatment margin. The MLC tracking is implemented by recalculating the radiation beam shape fit for the moved prostate and static nodal targets and sending the adjusted MLC leaf positions to the treatment delivery system. The actually delivered dose to the patient will be calculated after the treatment and compared to the dose without MLC tracking to assess the treatment efficacy.

Interventions

DEVICECombined real-time use of 'Multi-Leaf Collimator Adaptation' and 'kV Intrafraction Monitoring'

This intervention uses the simultaneous combined use of two technologies: 'Multi-Leaf Collimator Adaptation' and 'kV Intrafraction Monitoring'. kV Intrafraction Monitoring (KIM) measures the motion of tissues targeted for radiotherapy in real time using kV imaging.The multi-leaf collimator (MLC) reshapes the radiation beam to maximise dose to the target tissue and minimise dose to the surrounding healthy tissue. Combining KIM and MLC allows the shaped radiation beam to follow the moving target (the prostate) while remaining fixed on a stationary target (lymph nodes) that are also being treated at the same time.

Sponsors

Royal North Shore Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

All patients receive the intervention for comparison against retrospective matched cohort.

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients undergoing definitive external beam radiotherapy at Northern Sydney Cancer Centre * Patients histologically proven prostate adenocarcinoma * PSA obtained within 3 months prior to enrolment * Pelvic lymph nodes are included for treatment for patients at stage T1c-T3b with Gleason 8-10 or prostate-specific antigen (PSA) \> 20 ng/ml or pelvic lymph node positivity on conventional imaging or prostate-specific membrane antigen (PSMA) scans. * Patient must be able to have gold fiducial markers placed in the prostate * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Ability to understand and the willingness to sign a written informed consent document. * Prostate dimension that allows leaf span with tracking margin of ±8mm

Exclusion criteria

* Patients with artificial Hip(s), lumbar spinal surgical rods or other large metallic pelvic implants * Patient's dimensions \>40cm as measured at the level of the prostate * Patients with overlapping implanted gold fiducials in x-ray imaging

Design outcomes

Primary

MeasureTime frameDescription
Software or mechanical failureThe treatment period (2-9 weeks)The percentage of fractions delivered without software or mechanical failure

Secondary

MeasureTime frameDescription
Geometric accuracyThe treatment period (2-9 weeks)The geometric accuracy of the beam shape, determined by comparing the ideal beam shape with the actual beam shape.
Prostate motion trajectoryTreatment period (2-9 weeks)Prostate motion trajectory measured by KIM.
Dosimetric accuracyTreatment period (2-9 weeks)The estimated dose distributions will be compared to the original plan using the dose reconstruction method18 based on the prostate motion trajectory and the logged MLC positions (beam shapes).
Acute toxicityTreatment period (2-9 weeks) plus 3 monthsToxicity during treatment

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026