Can AI-Guided radiation tame lung tumors without the burn?
NCT ID NCT05785845
First seen Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time
Summary
This trial is testing a new radiation technique called CT-STAR for people with early-stage non-small cell lung cancer located near the center of the chest, where treatment is tricky. The approach uses a machine that takes CT images during each session and adapts the radiation plan in real time to spare nearby healthy organs. The goal is to see if this can safely deliver a shorter, more powerful course of radiation while reducing severe side effects compared to standard treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Computed tomography-guided stereotactic adaptive radiotherapy (CT-STAR) using the ETHOS system
- What this could lead to
- If successful, this approach could allow a shorter, more intense radiation course for hard-to-treat lung tumors while reducing severe side effects.
- What could go wrong
- This is an early-phase trial with a small number of participants, so results may not apply broadly. There is still a risk of serious side effects from radiation.
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
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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
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17 people
The number who actually took part.
- Started
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Apr 2023
- Finished
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Jun 2026
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Histologically or radiographically diagnosed stage I-IIA (AJCC, 8th ed.) non-small cell lung cancer or mediastinal recurrent non-small cell lung cancer with plans to be treated with definitive intent SBRT alone. * Clinical AJCC stage I defined as stage 1A1 (T1a1N0M0, T1a tumor less than or equal to 1 cm), stage 1A2 (T1bN0M0, T1b tumor between 1 and 2 cm), and stage 1A3 (T1cN0M0, T1c tumor between 2 and 3 cm). * Clinical AJCC stage IB defined as T2aN0M0, T2a tumor between 3 and 4 cm. * Clinical AJCC stage IIA defined as T2bN0M0, T2b tumor between 4 and 5 cm. * Lesions must be defined as central or ultra-central according to the Hilus-trial13 criteria: * Central lesions are defined as lesions 1 cm or less from the trachea, carina, main bronchi, bronchus intermedius, or lobar bronchi. * Ultra-central lesions are defined as lesions touching the trachea, carina, main bronchi, bronchus intermedius, or lobar bronchi. Lesions that touch the esophagus, great vessels, or heart may also be included as ultra-central. * Tumor coverage is deemed adequate in simulation treatment planning as determined by the treating and study physicians. Specifically, the dose to 98% of the GTV must be greater than 45 Gy. * Note: patients with inadequate tumor coverage at simulation will be considered screen-failures and treated off-protocol as per institutional standard-of-care. \*In a in silico analysis of these patients, only 1/6 patients screen-failed based on this inclusion criteria. * Patients should be able to hold their breath for 10 seconds. * Inoperable disease or patient has refused/declined surgery. * Deemed medically fit for SBRT by the treating physician. * At least 18 years of age. * Zubrod Performance Status 0-2 within 30 days prior to registration. * Appropriate stage for protocol entry based upon the following minimum diagnostic workup. * History/physical examination within 30 days prior to registration. * FDG-PET/CT scan and/or CT chest (with or without contrast) for staging within 60 days prior to registration. * Adequate bone marrow and hemostasis function determined no more than 30 days prior to registration, defined as follows: * Platelets ≥ 150,000 cells/mm3 * Hemoglobin ≥ 8 g/dl * Able to understand and willing to sign an IRB approved written informed consent. Exclusion Criteria: * Lesions appearing to extend through the bronchial or great vessel walls on CT imaging. * Prior or concurrent malignancies, unless the natural history of the prior or concurrent malignancy does not have the potential to interfere with the interpretation of the results of the study. * Patients with a pre-existing, active diagnosis of metastatic cancer. * Severe, active comorbidity, defined as follows: * Unstable angina, history of myocardial infarction and/or congestive heart failure requiring hospitalization within the last 6 months; * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; * Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration; * Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol. * Past history of radiotherapy within the projected treatment field of any of the disease sites to be treated by CT-guided SBRT. * Pregnant and/or breastfeeding. Patient must have a negative pregnancy test within 14 days of the start of SBRT.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Washington University School of Medicine
St Louis, Missouri, 63110, United States
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