Markerless Image Guidance Using Intrafraction Kilovoltage X-ray Imaging

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Устройство Markerless Image Guidance
  Single arm trial using implanted markers to determine the feasibility of Markerless Image Guidance using Intrafraction Kilovoltage X-ray Imaging

Первичные конечные точки

• Markerless Tumour Tracking is feasible for motion-adaptive lung cancer radiotherapy [Срок оценки: 2 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Австралия · 1 центр

• Alfred Health — Melbourne

Публикации

• Mueller M, Booth J, Briggs A, Jayamanne D, Panettieri V, Senthi S, Shieh CC, Keall P. MArkerless image Guidance using Intrafraction Kilovoltage x-ray imaging (MAGIK): study protocol for a phase I interventional study for lung cancer radiotherapy. BMJ Open. 2022 Jan 20;12(1):e057135. doi: 10.1136/bmjopen-2021-057135. PMID 35058267

Идентификаторы

NCT: NCT04086082 · MAGIK V1.0

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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