Markerless Image Guidance Using Intrafraction Kilovoltage X-ray Imaging (MAGIK)

January 8, 2024 updated by: University of Sydney

MAGIK: Using Implanted Markers to Determine the Feasibility of Markerless Image Guidance Using Intrafraction Kilovoltage X-ray Imaging: A Phase I Interventional Study of Lung Cancer Radiotherapy

This trial will investigate the feasibility of the Markerless Tumour Tracking technology.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Markerless Tumour Tracking will be integrated with existing treatment machines to provide real-time monitoring of tumour motion during treatment delivery. Eligible patients will be implanted with fiducial markers, which act as the ground truth for evaluating the accuracy of Markerless Tumour Tracking. The patients will undergo the current standard of care radiotherapy, with the exception that kilovoltage x-ray images will be acquired continuously during treatment delivery to enable Markerless Tumour Tracking.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Recruiting
        • Alfred Health
        • Contact:
        • Principal Investigator:
          • Sashendra Senthi, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Is willing to comply with all trial procedures and intends to provide written Informed Consent for participation in this trial.
  • Patients undergoing external beam radiotherapy.
  • Histologically proven Stage I NSCLC or oligometastatic lung metastases (3 or less).
  • MRI/4D-CT prior to insertion of fiducial markers.
  • Patient must be able to have fiducial markers placed in the lung (if on anticoagulants, must be cleared by LMO or cardiologist).
  • ECOG performance status 0-2.
  • A maximum of three metastases to the lung from any non-haematological malignancy. Multiple metastases will be treated separately.
  • 1 cm ≤ Tumour diameter in any dimension ≤ = 5 cm.
  • The distance between the tumour centroid and the top end of the diaphragm is <=10 cm.

Exclusion Criteria:

  • Patient has low respiratory performance as evaluated by the physicians.
  • Previous high-dose thoracic radiotherapy.
  • Less than one fiducial marker implanted in the lung.
  • Fiducial markers are too far from the tumour centroid (>9 cm).
  • Cytotoxic chemotherapy within 3 weeks of commencement of treatment, or concurrently with treatment. Hormonal manipulation agents are allowable (e.g. aromatase inhibitors, selective oestrogen receptor modulators, and gonadotropin releasing hormone receptor modulators).
  • Targeted agents (such as sunitinib, bevacizumab and tarceva) within 7 days of commencement of treatment, or concurrently with treatment.
  • Women who are pregnant or lactating.
  • Unwilling or unable to complete quality of life questionnaires.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Markerless Image Guidance Arm
Single arm trial using implanted markers to determine the feasibility of Markerless Image Guidance using Intrafraction Kilovoltage X-ray Imaging
Device: Markerless Image Guidance
Single arm trial using implanted markers to determine the feasibility of Markerless Image Guidance using Intrafraction Kilovoltage X-ray Imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Markerless Tumour Tracking is feasible for motion-adaptive lung cancer radiotherapy
Time Frame: 2 years

This will be measured by 90% of the treatment fractions achieving:

  1. Continuous on-line tracking with no software failure;
  2. Agreement between markerless and marker-based tracking within 3 mm in each direction (left-right, superior-inferior, anterior-posterior) for at least 80% of the beam-on time as assessed in off-line analyses.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sydney

Investigators

  • Principal Investigator: Paul Keall, PhD, University of Sydney

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

May 6, 2019

First Submitted That Met QC Criteria

September 9, 2019

First Posted (Actual)

September 11, 2019

Study Record Updates

Last Update Posted (Estimated)

January 11, 2024

Last Update Submitted That Met QC Criteria

January 8, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAGIK V1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified participant data and images will be made available for other scientific research.

IPD Sharing Time Frame

Data will be made available following publication of the final analysis, and for a minimum of 2 years thereafter.

IPD Sharing Access Criteria

Requests must be made to the original researchers for access to the data.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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