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

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.

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

Interventions

PROCEDURE

Computed Tomography

Undergo CT

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Positron Emission Tomography

Undergo PET

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Radiology, Treatment Planning

Undergo radiation planning with AI-directed analysis for dose recommendation

RADIATION

Stereotactic Body Radiation Therapy

Undergo SBRT

PROCEDURE

X-Ray Imaging

Undergo x-ray imaging

Sponsors & Collaborators

• Varian Medical Systems

  collaborator INDUSTRY

• National Cancer Institute (NCI)

  collaborator NIH

• Northwestern University

  lead OTHER

Principal Investigators

• Mohamed E Abazeed, MD, PhD · Northwestern University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-11-20

Primary Completion

2028-08-01

Completion

2031-08-01

FDA Device

Yes

Countries

• United States

Study Locations