RecruitingNot ApplicableNCT05802186

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

A Single-Arm Phase II Study of Personalized Dose Guidance for Stereotactic Body Radiotherapy (SBRT) in Patients With Lung Tumors


Sponsor

Northwestern University

Enrollment

70 participants

Start Date

Nov 20, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether an artificial intelligence tool can help radiation oncologists plan better, more personalized radiation treatment (called SBRT) for lung tumors — both primary lung cancers and cancer that has spread to the lungs from elsewhere in the body. **You may be eligible if:** - You are 18 or older - You have lung cancer (typically non-small cell) or a small number of tumors in the lung that came from another cancer - Your lung tumor(s) can be measured on imaging - You are in reasonably good general health (ECOG score 0–2) - If you could be pregnant, you have a negative pregnancy test **You may NOT be eligible if:** - Your cancer is not measurable on imaging - You are pregnant (radiation can harm a developing baby) - You are not willing to use contraception during the study period Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREComputed Tomography

Undergo CT

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

PROCEDUREPositron Emission Tomography

Undergo PET

OTHERQuality-of-Life Assessment

Ancillary studies

OTHERRadiology, Treatment Planning

Undergo radiation planning with AI-directed analysis for dose recommendation

RADIATIONStereotactic Body Radiation Therapy

Undergo SBRT

PROCEDUREX-Ray Imaging

Undergo x-ray imaging


Locations(1)

Northwestern University

Chicago, Illinois, United States

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NCT05802186


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