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No-Marker tumor tracking could make lung cancer radiation safer

NCT ID NCT04310891

Knowledge-focused Sponsor: Royal North Shore Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new X-ray technique to track lung tumors during radiation without needing implanted markers. Five adults with early-stage lung cancer will be observed to see if the markerless method matches the standard marker-based tracking within 3 millimeters. If it works, it could make radiotherapy less invasive and more comfortable.

What this could mean

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

Active substance
Markerless Tumour Tracking (intrafraction kilovoltage X-ray imaging)
What this could lead to
If successful, this could make lung cancer radiotherapy more accurate and less invasive by removing the need for implanted markers.
What could go wrong
This is a very small, early-phase study with only 5 participants, so results may not apply to all patients. The tracking method may not be accurate enough for routine use.

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.

Participants

5 people

The number who actually took part.

Started

Dec 2020

Expected to finish

Dec 2027

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.

Who is studied

Adults \>=18 years with NSCLC

Ages

18 to 80 years

Sex

Anyone

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: 1. Aged 18 or older. 2. Has provided written Informed Consent for participation in this trial and is willing to comply with the study. 3. Patients undergoing external beam radiotherapy. 4. Histologically proven Stage I NSCLC or oligometastatic lung metastases (3 or less). 5. Diagnostic CT prior to insertion of fiducial markers. 6. Patient must be able to have fiducial markers placed in the lung (if on anticoagulants, must be cleared by LMO or cardiologist). 7. ECOG performance status 0-2. 8. A maximum of three metastases to the lung from any non-haematological malignancy. Multiple metastases will be treated separately. 9. 1 cm ≤ Tumour diameter in any dimension ≤ = 5 cm. 10. The distance between the tumour centroid and the top end of the diaphragm is \<=8 cm. Exclusion Criteria: 1. Patient has low respiratory performance as evaluated by the physicians. 2. Previous high-dose thoracic radiotherapy. 3. Less than one fiducial marker implanted in the lung. 4. Fiducial markers are too far from the tumour centroid (\>9 cm). 5. 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). 6. Targeted agents (such as sunitinib, bevacizumab and tarceva) within 7 days of commencement of treatment, concurrently with treatment or 7 days after radiotherapy. 7. Women who are pregnant or lactating. 8. Unwilling or unable to give informed consent. 9. 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.

Intrafraction kolovoltage X-ray imaging Lung cancer Markerless image guidance

Contacts and locations

Locations

  • Royal North Shore Hospital

    Saint Leonards, New South Wales, 2065, Australia

More trials for these conditions

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