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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT05802186
Status
Recruiting
Apply to this trial

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Computed Tomography — PROCEDURE
    Undergo CT
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Positron Emission Tomography — PROCEDURE
    Undergo PET
  • Quality-of-Life Assessment — OTHER
    Ancillary studies
  • Radiology, Treatment Planning — OTHER
    Undergo radiation planning with AI-directed analysis for dose recommendation
  • Stereotactic Body Radiation Therapy — RADIATION
    Undergo SBRT
  • X-Ray Imaging — PROCEDURE
    Undergo x-ray imaging

Study Details

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.

Key Dates

Start date
Nov 20, 2023
Status verified
May 2026
Primary completion
Aug 1, 2026
Completion
Aug 1, 2031

Study Design

Enrollment
70 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (AI-directed analysis, SBRT)
    Patients undergo radiation planning with AI-directed analysis for dose recommendations with Deep Profiler + iGray software on study. Patients then undergo SBRT on study. Patients also undergo PET, CT, MRI, and/or x-ray imaging during screening and follow-up.

Primary Outcome Measure

Local failure free survival (LFS) [ Time Frame: Up to 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611
Mohamed E. Abazeed, MD, PhD
312-503-2195
Mohamed E. Abazeed, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chicago, IL

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Northwestern University· Chicago, IL

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