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Markerless Image Guidance Using Intrafraction Kilovoltage X-ray Imaging

RECRUITING

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

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2023-05-24

Primary completion: 2024-12-01

Study completion finish: 2028-12-01

Study type

TREATMENT

Phase

Trial ID

NCT04086082

Intervention or treatment

DEVICE: Markerless Image Guidance

Conditions

• Lung Cancer

Condition: Lung Cancer
DEVICE: Markerless Image Guidance
Melbourne, Victoria, Australia
Sponsor: University of Sydney

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Alfred Health

Research sites nearby

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Alfred Health
Melbourne, Victoria, Australia

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?

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

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

Secondary outcome

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: Markerless Image Guidance Using Intrafraction Kilovoltage X-ray Imaging