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RecruitingLast updated: 18 March 2024

MAGIK: This study is investigating how feasible a new Markerless Tumour Tracking technology is in people who are receiving radiation therapy for their lung cancerUsing 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

Clinical summary

Summary

Markerless Tumour Tracking is a device that will be integrated with existing treatment machines to provide real-time monitoring of the tumour motion during treatment delivery. Eligible participants will be implanted with fiducial markers, which act as the ground truth for evaluating the accuracy of Markerless Tumour Tracking. 

The participants will undergo the current standard of care radiation therapy, with the exception that kilovoltage x-ray images will be required continuously during treatment delivery to enable Markerless Tumour Tracking. 

Conditions

This trial is treating patients with non-small cell lung cancer or oligometastatic lung metastases (3 or less)

Cancer

Lung Cancers Lung cancer

Age

People18+

Phase

Not applicable

Trial Acronym

MAGIK

More information

Trial Identifiers

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Trial sponsor

University of Sydney

Scientific Title

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

Eligibility

Inclusion

  • 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

  • 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.

Inclusion

  • You are currently receiving treatment for your cancer.
  • You have had a certain type of treatment or surgical procedure.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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