Could X-Ray vision replace lung cancer marker implants?

NCT ID NCT04086082

Knowledge-focused Sponsor: University of Sydney Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a new technology that uses x-rays to track lung tumors during radiation therapy, without needing to implant markers in the lung. About 30 people with early-stage lung cancer or a few lung metastases will take part. The goal is to see if the markerless tracking is accurate enough to guide the radiation beam in real time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to: If successful, this technology could make lung cancer radiotherapy more precise and less invasive by removing the need for implanted markers.
What could go wrong: This is a small, early-phase feasibility study with only 30 participants. The technology may not work as well as hoped, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2023

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

lung cancer lung neoplasm non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lung cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Could X-Ray vision replace lung cancer marker implants?

What the study statuses mean