AI-Directed Radiation Therapy for Lung Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Mohamed E. Abazeed

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Northwestern University

Must not be taking: Genotoxic chemotherapy

Disqualifiers: Prior radiotherapy, Active infection, Unstable angina, others

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial tests if using AI to decide radiation doses can improve treatment for lung cancer patients. The AI aims to make radiation therapy more precise and effective, reducing the chance of cancer returning. The study will see if this approach helps patients live longer without their cancer getting worse and if it is safe and practical to use in real-life settings.

Will I have to stop taking my current medications?

The trial requires patients to pause targeted therapy medications 3 days before and restart them at least 3 days after the radiation therapy. Other medications, including non-investigational immunotherapy and COVID-19 vaccinations, are allowed.

What data supports the effectiveness of the treatment AI-Directed Dose Recommendation, Stereotactic Body Radiation Therapy, SBRT, Stereotactic Ablative Radiotherapy, SABR, Stereotactic Body Radiation Therapy, Stereotactic Ablative Radiotherapy (SABR), CyberKnife for lung cancer?

Research shows that Stereotactic Ablative Radiotherapy (SABR), especially using the CyberKnife system, is effective for treating early-stage non-small cell lung cancer, offering high rates of local tumor control with acceptable side effects. It is particularly beneficial for patients who cannot undergo surgery, providing a precise and non-invasive treatment option. ^{1 2 3 4 5}

Is AI-Directed Radiation Therapy for Lung Cancer safe for humans?

Stereotactic Ablative Radiotherapy (SABR) using the CyberKnife system has been shown to have acceptable safety levels, with manageable side effects, when used for treating lung cancer. Studies indicate that it provides good tumor control with a short treatment duration, making it a safe option for patients who cannot undergo surgery. ^{1 2 3 4 6}

How is the treatment AI-Directed Radiation Therapy for Lung Cancer different from other treatments?

AI-Directed Radiation Therapy using the CyberKnife system is unique because it delivers high doses of radiation with precision to lung tumors that move with breathing, using a robotically-controlled system that adjusts in real-time. This allows for effective treatment in fewer sessions compared to conventional radiotherapy, making it suitable for patients who cannot undergo surgery. ^{1 2 3 4 5}

Eligibility Criteria

Adults (18+) with primary lung cancer or a few metastatic tumors in the lungs, able to perform daily activities (ECOG 0-2), and not pregnant can join. They must understand and sign consent. Excluded are those with prior overlapping radiotherapy, unresolved thoracic toxicities from past treatments, concurrent investigational drugs, other interfering malignancies, or uncontrolled illnesses.

Inclusion Criteria

Patients must have visible signs of disease on a medical scan that can be measured according to specific guidelines.

My lung scans show signs of cancer, either as a primary condition or with few spread sites.

I am 18 years old or older.

Exclusion Criteria

If you have a specific type of lung cancer that appears as only hazy spots on a scan, you will not be included in the study.

I do not have another cancer or serious illness that could affect the study.

I still have side effects from cancer treatment in my chest area, except for hair loss or low blood counts.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Radiation Planning

Radiation planning with AI-directed analysis for dose recommendations using Deep Profiler + iGray software

1 week

1 visit (in-person)

Treatment

Participants undergo stereotactic body radiation therapy (SBRT) with AI-directed dose recommendations

1-2 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including imaging and respiratory function assessment

5 years

Regular visits (in-person)

Treatment Details

Interventions

• AI-Directed Dose Recommendation (Artificial Intelligence)
• Stereotactic Body Radiation Therapy (Radiation Therapy)

Trial Overview The RAD-AI study is testing if AI can improve dose recommendations during SBRT for lung cancer treatment. It aims to see if personalized AI predictions lead to better outcomes by reducing local recurrence of the disease while minimizing damage to healthy tissue.

Participant Groups

Group I: Treatment (AI-directed analysis, SBRT) Experimental Treatment 7 Interventions

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.

Stereotactic Body Radiation Therapy is already approved in United States, European Union, Canada, Australia for the following indications:

🇺🇸 Approved in United States as Stereotactic Body Radiation Therapy for:

• Non-small cell lung cancer (NSCLC)
• Melanoma
• Renal cell carcinoma (RCC)
• Prostate cancer
• Oligoprogressive cancers

🇪🇺 Approved in European Union as Stereotactic Body Radiation Therapy for:

• Non-small cell lung cancer (NSCLC)
• Melanoma
• Renal cell carcinoma (RCC)
• Prostate cancer
• Oligoprogressive cancers

🇨🇦 Approved in Canada as Stereotactic Body Radiation Therapy for:

• Non-small cell lung cancer (NSCLC)
• Melanoma
• Renal cell carcinoma (RCC)
• Prostate cancer
• Oligoprogressive cancers

🇦🇺 Approved in Australia as Stereotactic Body Radiation Therapy for:

• Non-small cell lung cancer (NSCLC)
• Melanoma
• Renal cell carcinoma (RCC)
• Prostate cancer
• Oligoprogressive cancers

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Northwestern University Chicago, IL

Who Is Running the Clinical Trial?

Northwestern University Lead Sponsor

Varian Medical Systems Industry Sponsor

National Cancer Institute (NCI) Collaborator

References

1. United States pubmed.ncbi.nlm.nih.gov

CyberKnife stereotactic ablative radiotherapy for lung tumors. [2022] Stereotactic ablative radiotherapy (SABR) has emerged as a promising treatment for early stage non-small cell lung cancer, particularly for patients unable to tolerate surgical resection. High rates of local tumor control have been demonstrated with acceptable toxicity and the practical advantage of a short course of treatment. The CyberKnife image-guided robotic radiosurgery system has unique technical characteristics that make it well suited for SABR of tumors that move with breathing, including lung tumors. We review the qualities of the CyberKnife platform for lung tumor SABR, and provide a summary of clinical data using this system specifically.

2. Switzerland pubmed.ncbi.nlm.nih.gov

Definitive Treatment of Early-Stage Non-Small Cell Lung Cancer with Stereotactic Ablative Body Radiotherapy in a Community Cancer Center Setting. [2020] Stereotactic ablative body radiotherapy (SABR) provides a superior non-small cell lung cancer (NSCLC) treatment option when compared to conventional radiotherapy for patients deemed inoperable or refusing surgery. This study retrospectively analyzed the rates of tumor control and toxicity following SABR treatment (Cyberknife system) of primary early-stage NSCLC in a community setting.

3. Greece pubmed.ncbi.nlm.nih.gov

Stereotactic Ablative Radiotherapy Using CyberKnife for Stage I Non-small-cell Lung Cancer: A Retrospective Analysis. [2022] We evaluated the effectiveness and safety of stereotactic ablative radiotherapy (SABR) delivered using Cyberknife in patients with stage I non-small-cell lung cancer.

4. England pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiotherapy with a central high dose using CyberKnife for metastatic lung tumors. [2023] The CyberKnife system features a robotically-positioned linear accelerator to deliver real-time image-guided stereotactic ablative body radiotherapy (SABR). It achieves steep dose gradients using irradiation from hundreds of different directions and increases the central dose of the gross tumor volume (GTV) without increasing the marginal dose to the planning target volume. We evaluated the effectiveness and safety of SABR with a central high dose using CyberKnife for metastatic lung tumors.

5. United States pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy (SABR) for non-small cell lung cancer. [2013] Stereotactic ablative radiotherapy (SABR), otherwise known as stereotactic body radiation therapy (SBRT), is an external beam treatment modality that offers the ability to deliver with high precision large doses of radiation over a limited number of fractions. SABR is currently a standard of care in the treatment of early-stage primary non-small cell lung cancers (NSCLCs) that are medically inoperable and for metastases in many anatomical locations. To date, local control and toxicity parameters with SABR for early-stage NSCLCs are comparable to those found in reports of experiences with surgical resection. It is increasingly apparent that some patients with borderline resectable lung primaries are also looking to SABR as a noninvasive means of therapy. However, randomized comparisons have not been completed to assess survival in operable patients. This review summarizes the advanced technology and radiation concepts that have helped clinicians optimize the use of stereotactic ablative therapies for lung cancer, with an emphasis on the rationale for future continued use of this advanced treatment modality.

6. United States pubmed.ncbi.nlm.nih.gov

Colorectal Histology Is Associated With an Increased Risk of Local Failure in Lung Metastases Treated With Stereotactic Ablative Radiation Therapy. [2022] Stereotactic ablative radiation therapy (SABR) is increasingly used to treat lung oligometastases. We set out to determine the safety and efficacy of this approach and to identify factors associated with outcomes.