Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05802186

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Northwestern University

Chicago, Illinois, United States, 60611

Actively Recruiting

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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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