Lung CarcinomaNCT05802186
Stereotactic Body Radiation Therapy Planning With Artificial Intelligence-Directed Dose Recommendation for Treatment of Primary or Metastatic Lung Tumors, RAD-AI Study
A study testing Computed Tomography, Magnetic Resonance Imaging and Positron Emission Tomography in people with Lung Carcinoma and Lung Non-Small Cell Carcinoma, run by Northwestern University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Carcinoma, Lung Non-Small Cell Carcinoma, Metastatic Malignant Neoplasm in the Lung
- What is being tested?
- Computed Tomography, Magnetic Resonance Imaging and Positron Emission Tomography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2023to 1 Aug 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with radiographic findings consistent with lung cancer or solitary or oligometastatic disease in the lung. Most patients will have primary non-small cell lung cancer. For primary lung cancers, we include lesions with ground glass opacities with a solid component of 50% or greater. Patients with solitary or oligo-metastatic disease in the lung may have any other histology or cancer type.
- Patients must have radiographically measurable or evaluable disease per RECIST v. 1.1.
- Patients must be age >= 18 years.
- Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Patients of child-bearing potential (POCBP) must have a negative urine or serum pregnancy test prior to registration on study.
- NOTE: A POCBP is any person with an egg-producing reproductive tract (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
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- Has not undergone a hysterectomy or bilateral oophorectomy
- Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for > 12 months)
- Radiation therapy is known to be teratogenic. Patients of child-bearing potential (POCBP) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from time of informed consent, for the duration of study participation, and for 7 days following completion of therapy. Should a patient become pregnant or suspect they are pregnant while they or their partner are participating in this study, they should inform their treating physician immediately. People who can impregnate their partners treated or enrolled on this protocol must also agree to use adequate contraception from time of informed consent, for the duration of study participation, and 90 days after completion of administration.
- Patients must have the ability to understand and the willingness to sign a written informed consent document. Informed consent must be signed prior to registration on study.
Who cannot join
- Patients who have had prior radiotherapy with radiation field overlap.
- For primary lung cancers, patients with ground glass opacities without a solid component will be excluded.
- Patients who have not recovered from adverse events confined to the thorax (i.e. pneumonitis, bronchial insufficiency, bronchial hemorrhage, esophagitis) due to prior anticancer therapy (i.e., have residual toxicities >= grade 2) with the exception of alopecia. low blood counts (neutropenia, anemia, etc), or anatomically distinct toxicities (i.e. cystitis).
- Patients who are receiving any other concurrent investigational agents or genotoxic chemotherapy for cancer treatment.
- Note: Patients receiving targeted therapies are permitted to enroll on the study. However, patients must pause treatment with targeted therapy 3 days prior to SBRT and restart medication at least 2 days after SBRT. Concurrent immunotherapy (if not investigational) is permitted. Coronavirus disease 2019 (COVID-19) vaccinations are allowed.
- Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients who have an uncontrolled intercurrent illness including, but not limited to any of the following, are not eligible:
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- Ongoing or active infection requiring systemic treatment
- Unstable angina pectoris
- Stage 3 or greater idiopathic pulmonary fibrosis
- Cardiac arrhythmia
- Psychiatric illness/social situations that would limit compliance with study requirements
- Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints
- Female patients who are pregnant or nursing. Pregnant women are excluded from this study because radiation therapy has teratogenic or abortifacient effects.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Mohamed E. Abazeed, MD, PhD, 312-503-2195
Mohamed E. Abazeed, MD, PhD
About this study
Official title: A Single-Arm Phase II Study of Personalized Dose Guidance for Stereotactic Body Radiotherapy (SBRT) in Patients With Lung Tumors
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To obtain preliminary evidence of efficacy (reduction in local failure free survival) in patients receiving SBRT to the lung with personalized artificial intelligence dose guidance (Deep Profiler + iGray).
SECONDARY OBJECTIVES:
- To evaluate progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) version (v.) 1.1 in patients receiving individualized radiation doses to the lung as recommended by Deep Profiler + iGray.
II. To evaluate the feasibility, defined as 85% receiving within 10% of the projected dose, of implementing the individualized radiation doses recommended by machine learning software (Deep Profiler + iGray) in a clinical practice.
III. To assess toxicity per Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0 in patients receiving individualized radiation doses to the lung as recommended by Deep Profiler + iGray.
IV. To evaluate respiratory function per the RTOG Pulmonary Function Scale.
OUTLINE:
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 positron emission tomography (PET), computed tomography (CT), magnetic resonance imaging (MRI), and/or x-ray imaging during screening and follow-up.
- 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
- Being tested
- Computed Tomography, Magnetic Resonance Imaging, Positron Emission Tomography, Quality-of-Life Assessment, Radiology, Treatment Planning
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR
Undergo MRI
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan
Undergo PET
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Radiology, Treatment PlanningOther
Undergo radiation planning with AI-directed analysis for dose recommendation
Stereotactic Body Radiation TherapyRadiation
Also called SABR, SBRT, Stereotactic Ablative Body Radiation Therapy
Undergo SBRT
X-Ray ImagingProcedure or surgery
Also called Conventional X-Ray, Diagnostic Radiology, Medical Imaging, X-Ray, Plain film radiographs
Undergo x-ray imaging
| Study group | Role | What they receive |
|---|---|---|
| Treatment (AI-directed analysis, SBRT) | Experimental | 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. Receives: Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Other: Quality-of-Life Assessment; Other: Radiology, Treatment Planning; Radiation: Stereotactic Body Radiation Therapy; Procedure: X-Ray Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local failure free survival (LFS)
LFS is defined as the length of time after SBRT that the patient survives without local failure (as assessed by tumor imaging). LFS data will be collected from the end of SBRT, until the patient experiences recurrence, completes the 5-year follow-up after SBRT, or experiences death from any cause (whichever is sooner). The LFS at 2 years after completion of SBRT will be calculated based on Kaplan-Meier estimates
Measured: Up to 5 years
Secondary outcomes (4)
Progression-free survival (PFS)
For PFS analysis, disease progression is defined as progressive disease per Response Evaluation Criteria in Solid Tumors version 1.1.
Measured: Assessed at 2 years
Respiratory function
To assess the respiratory toxicity of SBRT doses as recommended by Deep Profiler +iGray, this endpoint will collect and report the frequency of adverse events by type, severity (grade), timing, and attribution, according the RTOG Pulmonary Function Test Toxicity Scale.
Measured: Up to 30 days
Incidence of adverse events
To assess the Toxicity Profile of SBRT fractions as recommended by Deep Profiler +iGray, this endpoint will collect and report the frequency of adverse events by type, severity (grade), timing, and attribution, according the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0.
Measured: Up to 30 days
Adherence to recommended dose
To evaluate if individualized radiation doses recommended by machine learning software (Deep Profiler +iGray) can be implemented in a clinical practice (feasibility), we will assess the adherence of the prescribing physician to the dose recommended by the Deep Profiler +iGray during the 1-2 week period of SBRT. The adherence to the dose recommended by the Deep Profiler +iGray will be reported.
Measured: During the 1-2 weeks period of SBRT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start20 Nov 2023
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Varian Medical Systems, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Mohamed E Abazeed, MD, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05802186
- Sponsor's protocol ID
- NU 21L04
- Other IDs
- NCI-2023-01822, STU00217995, NU 21L04, P30CA060553
- Status last verified
- May 2026
- First submitted
- 24 Mar 2023
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm Phase II Study of Personalized Dose Guidance for Stereotactic Body Radiotherapy (SBRT) in Patients With Lung Tumors
- ClinicalTrials.gov ID
- NCT05802186
- Acronym / sponsor ID
- NU 21L04
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Varian Medical Systems, National Cancer Institute (NCI)
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2031 (estimated)
- First posted
- 6 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- To obtain preliminary evidence of efficacy (reduction in local failure free survival) in patients receiving SBRT to the lung with personalized artificial intelligence dose guidance (Deep Profiler + iGray).
SECONDARY OBJECTIVES:
- To evaluate progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) version (v.) 1.1 in patients receiving individualized radiation doses to the lung as recommended by Deep Profiler + iGray.
II. To evaluate the feasibility, defined as 85% receiving within 10% of the projected dose, of implementing the individualized radiation doses recommended by machine learning software (Deep Profiler + iGray) in a clinical practice.
III. To assess toxicity per Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0 in patients receiving individualized radiation doses to the lung as recommended by Deep Profiler + iGray.
IV. To evaluate respiratory function per the RTOG Pulmonary Function Scale.
OUTLINE:
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 positron emission tomography (PET), computed tomography (CT), magnetic resonance imaging (MRI), and/or x-ray imaging during screening and follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (AI-directed analysis, SBRT) | Experimental | Procedure: Computed Tomography, Procedure: Magnetic Resonance Imaging, Procedure: Positron Emission Tomography, Other: Quality-of-Life Assessment, Other: Radiology, Treatment Planning, Radiation: Stereotactic Body Radiation Therapy, Procedure: X-Ray ImagingPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with radiographic findings consistent with lung cancer or solitary or oligometastatic disease in the lung. Most patients will have primary non-small cell lung cancer. For primary lung cancers, we include lesions with ground glass opacities with a solid component of 50% or greater. Patients with solitary or oligo-metastatic disease in the lung may have any other histology or cancer type.
- Patients must have radiographically measurable or evaluable disease per RECIST v. 1.1.
- Patients must be age >= 18 years.
- Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Patients of child-bearing potential (POCBP) must have a negative urine or serum pregnancy test prior to registration on study.
Key exclusion criteria (13 listed)
- Patients who have had prior radiotherapy with radiation field overlap.
- For primary lung cancers, patients with ground glass opacities without a solid component will be excluded.
- Patients who have not recovered from adverse events confined to the thorax (i.e. pneumonitis, bronchial insufficiency, bronchial hemorrhage, esophagitis) due to prior anticancer therapy (i.e., have residual toxicities >= grade 2) with the exception of alopecia. low blood counts (neutropenia, anemia, etc), or anatomically distinct toxicities (i.e. cystitis).
- Patients who are receiving any other concurrent investigational agents or genotoxic chemotherapy for cancer treatment.
- Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients who have an uncontrolled intercurrent illness including, but not limited to any of the following, are not eligible:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo CT | Procedure or surgery | Treatment (AI-directed analysis, SBRT) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRUndergo MRI | Procedure or surgery | Treatment (AI-directed analysis, SBRT) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography ScanUndergo PET | Procedure or surgery | Treatment (AI-directed analysis, SBRT) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Treatment (AI-directed analysis, SBRT) |
| Radiology, Treatment PlanningUndergo radiation planning with AI-directed analysis for dose recommendation | Other | Treatment (AI-directed analysis, SBRT) |
| Stereotactic Body Radiation TherapyAlso: SABR, SBRT, Stereotactic Ablative Body Radiation TherapyUndergo SBRT | Radiation | Treatment (AI-directed analysis, SBRT) |
| X-Ray ImagingAlso: Conventional X-Ray, Diagnostic Radiology, Medical Imaging, X-Ray, Plain film radiographsUndergo x-ray imaging | Procedure or surgery | Treatment (AI-directed analysis, SBRT) |
Primary outcome
Local failure free survival (LFS)
Time frame: Up to 5 years
LFS is defined as the length of time after SBRT that the patient survives without local failure (as assessed by tumor imaging). LFS data will be collected from the end of SBRT, until the patient experiences recurrence, completes the 5-year follow-up after SBRT, or experiences death from any cause (whichever is sooner). The LFS at 2 years after completion of SBRT will be calculated based on Kaplan-Meier estimates
4 secondary outcomes
Progression-free survival (PFS)
Time frame: Assessed at 2 years
Respiratory function
Time frame: Up to 30 days
Incidence of adverse events
Time frame: Up to 30 days
Adherence to recommended dose
Time frame: During the 1-2 weeks period of SBRT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamed E Abazeed, MD, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computed Tomography, Magnetic Resonance Imaging and Positron Emission Tomography in people with Lung Carcinoma and Lung Non-Small Cell Carcinoma, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Coordinator (3126951301, cancer@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local failure free survival (LFS) (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.