Status:

UNKNOWN

Markerless Image Guidance Using Intrafraction Kolovoltage X-ray Imaging for Lung Cancer Radiotherapy

Lead Sponsor:

Royal North Shore Hospital

Collaborating Sponsors:

University of Sydney

Conditions:

Lung Cancer

Markerless Image Guidance

Eligibility:

All Genders

18-80 years

Brief Summary

In radiotherapy, tumour tracking allows us to ensure the radiation beam is accurately targeting the tumour while it moves in a complex and unpredictable way. Most tumour tracking techniques require th...

Detailed Description

We will perform a phase I observational trial investigating the feasibility of the Markerless Tumour Tracking technology. Markerless Tumour Tracking will be integrated with existing treatment machines...

Eligibility Criteria

Inclusion

  • Aged 18 or older.
  • Has provided written Informed Consent for participation in this trial and is willing to comply with the study.
  • Patients undergoing external beam radiotherapy.
  • Histologically proven Stage I NSCLC or oligometastatic lung metastases (3 or less).
  • Diagnostic 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 \<=8 cm.

Exclusion

  • 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, concurrently with treatment or 7 days after radiotherapy.
  • Women who are pregnant or lactating.
  • Unwilling or unable to give informed consent.
  • Unwilling or unable to complete quality of life questionnaires.

Key Trial Info

Start Date :

December 4 2020

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 31 2025

Estimated Enrollment :

10 Patients enrolled

Trial Details

Trial ID

NCT04310891

Start Date

December 4 2020

End Date

December 31 2025

Last Update

November 18 2023

Active Locations (1)

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Royal North Shore Hospital

Saint Leonards, New South Wales, Australia, 2065