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Precision radiation tackles lung tumors near vital airways

NCT ID NCT04925583

Disease control Sponsor: University Hospital Heidelberg 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 1 trial tests a special type of radiation therapy for lung tumors located very close to the windpipe or esophagus. Using real-time MRI guidance, doctors can adapt the radiation dose daily to target the tumor while sparing nearby organs. Up to 38 patients will receive one of four dose levels to find the safest highest dose. The study monitors for side effects over 12 months and checks for tumor return over 24 months.

What this could mean

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

Active substance
Stereotactic body radiotherapy (SBRT) using a MR-linac system
What this could lead to
If successful, this could establish a safer way to deliver high-dose radiation to lung tumors that are hard to treat because they are near the windpipe or food pipe.
What could go wrong
This is a very early phase 1 trial with only 38 people, focused on finding the highest safe dose. It is not designed to prove the treatment works, and there are risks of lung, esophagus, or heart side effects.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 38 people

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

Started

Nov 2021

Expected to finish

Nov 2030

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: * ultracentral location of the lung tumor, which is defined as an expected contact or overlap of the planning target volume with the proximal bronchial tree or esophagus at the time of consultation * indication for SBRT of the ultracentral pulmonary tumor * maximum diameter of the ultracentral pulmonary tumor \< 5cm * age \> 18 years of age * Karnofsky Performance Score \> 70% (ECOG Score 0 - 2) * ability to lie still on the MR-linac table for at least one hour * ability to hold one's breath for more than 20 seconds * successful completion of MRgRT simulation * for women with childbearing potential, adequate contraception. * ability of subject to understand character and individual consequences of the clinical trial * written informed consent (must be available before enrolment in the trial) Exclusion Criteria: * refusal of the patients to take part in the study * previous radiotherapy of the lung and mediastinum, if previous and current target volumes overlap * patients who have not yet recovered from acute toxicities of prior therapies * (planned) treatment with vascular endothelial growth factor (VEGF) inhibitors, e.g. Bevacizumab, within the time interval 2 weeks before and 2 weeks after SBRT * pregnant or lactating women * contraindications against performing MRI scans (pacemakers, other implants making MRI impossible) * participation in another competing clinical study or observation period of competing trials

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Conditions

The condition(s) this trial relates to.

lung cancer lung neoplasm

As listed by the trial registrant

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

Lung cancer

Contacts and locations

Locations

  • University Hospital of Heidelberg, Radiation Oncology

    Heidelberg, 69120, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.