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AI-Directed Radiation Planning for Lung Tumors (RAD-AI Study)

This study is testing a new way to plan radiation therapy for lung tumors using artificial intelligence (AI). It's called the RAD-AI Study. If you have lung cancer or cancer that has spread to your lungs, you might be able to join. The study will use AI to recommend the best radiation dose during stereotactic body radiation therapy (SBRT), a precise type of radiation. Researchers want to see if this AI-guided planning can reduce the chance of the cancer coming back in the treated area. They will also look at how long people live without the cancer growing and check for any side effects. The study aims to enroll 70 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It is not specified if it's randomized or blinded, but it plans to enroll 70 participants.
What's involved
You would undergo radiation planning with AI-directed analysis, then receive SBRT. You will also have imaging tests like PET, CT, MRI, and/or X-rays during screening and follow-up.
Compensation
Not stated in the trial record.
Follow-up
The study will follow participants for up to 5 years to measure how long they live without the cancer returning in the treated area.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05802186

Stereotactic Body Radiation Therapy Planning With Artificial Intelligence-Directed Dose Recommendation for Treatment of Primary or Metastatic Lung Tumors, RAD-AI Study

Recruiting
NAAges 18+InterventionalTreatment
Northwestern University
~70 participants
Updated 2026-05-29 on ClinicalTrials.gov
What's tested:Computed TomographyMagnetic Resonance ImagingPositron Emission TomographyQuality-of-Life AssessmentRadiology, Treatment PlanningStereotactic Body Radiation Therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Local failure free survival (LFS)
Measured over Up to 5 years

Conditions

Lung Carcinoma
Lung Non-Small Cell Carcinoma
Metastatic Malignant Neoplasm in the Lung
Stage I Lung Cancer AJCC v8
Stage II Lung Cancer AJCC v8
Stage IIIA Lung Cancer AJCC v8

Explore related trials

Lung Non-Small Cell CarcinomaMalignant Neoplasm

Where it's being run

1 sites across 1 states
Illinois1

Study leadership

  • Mohamed E Abazeed, MD, PhD · PRINCIPAL_INVESTIGATOR · Northwestern University

Who to contact

Study Coordinator
[email protected]
3126951301
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patients with radiographic findings consistent with lung cancer or solitary or oligometastatic disease in the lung. Most patients will have primary non-small cell lung cancer. For primary lung cancers, we include lesions with ground glass opacities with a solid component of 50% or greater. Patients with solitary or oligo-metastatic disease in the lung may have any other histology or cancer type.
Patients must have radiographically measurable or evaluable disease per RECIST v. 1.1.
Patients must be age \>= 18 years.
Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Patients of child-bearing potential (POCBP) must have a negative urine or serum pregnancy test prior to registration on study.
NOTE: A POCBP is any person with an egg-producing reproductive tract (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
Has not undergone a hysterectomy or bilateral oophorectomy
Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \> 12 months)
Radiation therapy is known to be teratogenic. Patients of child-bearing potential (POCBP) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from time of informed consent, for the duration of study participation, and for 7 days following completion of therapy. Should a patient become pregnant or suspect they are pregnant while they or their partner are participating in this study, they should inform their treating physician immediately. People who can impregnate their partners treated or enrolled on this protocol must also agree to use adequate contraception from time of informed consent, for the duration of study participation, and 90 days after completion of administration.
Patients must have the ability to understand and the willingness to sign a written informed consent document. Informed consent must be signed prior to registration on study.

Exclusion

Patients who have had prior radiotherapy with radiation field overlap.
For primary lung cancers, patients with ground glass opacities without a solid component will be excluded.
Patients who have not recovered from adverse events confined to the thorax (i.e. pneumonitis, bronchial insufficiency, bronchial hemorrhage, esophagitis) due to prior anticancer therapy (i.e., have residual toxicities \>= grade 2) with the exception of alopecia. low blood counts (neutropenia, anemia, etc), or anatomically distinct toxicities (i.e. cystitis).
Patients who are receiving any other concurrent investigational agents or genotoxic chemotherapy for cancer treatment.
Note: Patients receiving targeted therapies are permitted to enroll on the study. However, patients must pause treatment with targeted therapy 3 days prior to SBRT and restart medication at least 2 days after SBRT. Concurrent immunotherapy (if not investigational) is permitted. Coronavirus disease 2019 (COVID-19) vaccinations are allowed.
Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients who have an uncontrolled intercurrent illness including, but not limited to any of the following, are not eligible:
Ongoing or active infection requiring systemic treatment
Unstable angina pectoris
Stage 3 or greater idiopathic pulmonary fibrosis
Cardiac arrhythmia
Psychiatric illness/social situations that would limit compliance with study requirements
Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints
Female patients who are pregnant or nursing. Pregnant women are excluded from this study because radiation therapy has teratogenic or abortifacient effects.

What this trial measures

  • Local failure free survival (LFS)Up to 5 years

    LFS is defined as the length of time after SBRT that the patient survives without local failure (as assessed by tumor imaging). LFS data will be collected from the end of SBRT, until the patient experiences recurrence, completes the 5-year follow-up after SBRT, or experiences death from any cause (whichever is sooner). The LFS at 2 years after completion of SBRT will be calculated based on Kaplan-Meier estimates