Actively Recruiting
Stereotactic Body Radiation Therapy Planning With Artificial Intelligence-Directed Dose Recommendation for Treatment of Primary or Metastatic Lung Tumors, RAD-AI Study
Led by Northwestern University · Updated on 2025-10-08
70
Participants Needed
1
Research Sites
118 weeks
Total Duration
On this page
Sponsors
N
Northwestern University
Lead Sponsor
V
Varian Medical Systems
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial tests the effectiveness and safety of artificial intelligence (AI) to determine dose recommendation during stereotactic body radiation therapy (SBRT) planning in patients with primary lung cancer or tumors that has spread from another primary site to the lung (metastatic). SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Even with the high precision of SBRT, disease persistence or reappearance (local recurrence) can still occur, which could be attributed to the radiation dose. AI has been used in other areas of healthcare to automate and improve various aspects of medical science. Because the relationship of dose and local recurrence indicates that dose prescriptions matter, decision support systems to help guide dose based on personalized prediction AI algorithms could better assist providers in prescribing the radiation dose of lung stereotactic body radiation therapy treatment.
CONDITIONS
Official Title
Stereotactic Body Radiation Therapy Planning With Artificial Intelligence-Directed Dose Recommendation for Treatment of Primary or Metastatic Lung Tumors, RAD-AI Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with lung cancer or solitary/oligometastatic lung tumors, including primary non-small cell lung cancer with solid component \u226550% for ground glass opacities
- Radiographically measurable or evaluable disease per RECIST v. 1.1
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Negative pregnancy test for patients of child-bearing potential prior to registration
- Agreement to use contraception from consent through study participation and post-treatment period as specified
- Ability to understand and willingness to sign informed consent
You will not qualify if you...
- Prior radiotherapy with overlapping radiation fields
- Primary lung cancers with ground glass opacities lacking a solid component
- Unresolved thoracic adverse events from prior cancer therapy of grade 2 or higher (excluding alopecia, low blood counts, or unrelated toxicities)
- Receiving other concurrent investigational agents or genotoxic chemotherapy (targeted therapies allowed with specified pause around SBRT; non-investigational immunotherapy permitted)
- Prior or concurrent malignancies that might interfere with safety or efficacy assessment
- Uncontrolled illness such as active infections, unstable angina, severe pulmonary fibrosis, cardiac arrhythmia, psychiatric or social issues limiting compliance, or any condition compromising safety or study outcomes
- Pregnant or nursing females
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
S
Study Coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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