An interventional study of Artificial Intelligence-based Intervention and Best Practice in Lung Carcinoma, Lung Non-Small Cell Carcinoma and Metastatic Malignant Neoplasm in the Lung, sponsored by Northwestern University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Northwestern University · Not applicable, Interventional, and Treatment
Among 15 studies in Lung Neoplasms by Northwestern University — 4 open to participants now, 5 under way, none of them phase 3. Lung Neoplasms · Northwestern University.
Among the 15 studies in Lung Neoplasms by Northwestern University, this one is the 7th largest by planned enrollment of the 10 interventional ones, is the only one that started in 2027, is one of 2 with no phase, and was the 15th registered.
5,422 studies on the registry are indexed under Lung Neoplasms; 1,346 are open to participants now.
This study's planned enrollment of 34 is below the median of 60 across 3,656 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →4 of the 15 studies in Lung Neoplasms by Northwestern University are open now, in 1 country. Each count lists the studies.
Of the 996 Lung Neoplasms studies recruiting now, 683 (69%) set no upper age limit and 142 (14%) stop at 75 or younger; 45 take children under 18; 142 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →15 studies; the count open now beside each. This study's row is marked.
First in 1999; this study’s year is marked. 1 started in 2027.
Median enrollment 37 across the 10 interventional studies, 125 across the 1 observational. Of the 9 that completed or were terminated, 1 (11%) have results posted.
Northwestern University is the lead sponsor of 1,423 studies on the registry; 198 are open to participants now.
Of its 105 completed or terminated interventional studies of FDA-regulated products, 78 (74%) have results posted.
1 of the studies in Lung Neoplasms by Northwestern University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04931017Northwestern UniversityMetformin for Chemoprevention of Lung Cancer in Overweight or Obese Individuals at High Risk for Lung Cancer | 2026-12-31 |
Among the 15 studies in Lung Neoplasms by Northwestern University, from their registry updates:
This clinical trial studies whether an artificial intelligence (AI) software tool called iSeg can be safely and effectively used during routine radiation treatment planning for patients with lung tumors. Typical radiation treatment planning involves physicians manually outlining the tumors to plan where the radiation therapy will be delivered. This process can be time consuming and may vary between physicians. iSeg uses AI to analyze computed tomography (CT) images and generate a proposed tumor outline that can then be reviewed and modified by the treating physician during radiation treatment planning which may help improve accuracy and provide more consistent results and better planning. iSeg may be safe and effective to use during radiation treatment planning for patients with lung tumors.
PRIMARY OBJECTIVES:
I. To assess contouring time for physician versus iSeg workflows for early-stage non-small cell lung cancer (NSCLC) and patients with oligo-metastatic disease to the lung.
II. To assess preliminary efficacy of integrating iSeg into standard-of-care radiotherapy for early-stage non-small cell lung cancer (NSCLC) and patients with oligo-metastatic disease to the lung.
SECONDARY OBJECTIVES:
I. To evaluate progression local control (LC) in patients receiving individualized segmentation to the lung as recommended by iSeg.
II. To evaluate progression free survival (PFS) in patients receiving individualized segmentation to the lung as recommended by iSeg.
III. To assess toxicity in patients receiving individualized segmentation as recommended by iSeg.
IV. To assess toxicity per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 6.0 in patients receiving individualized segmentation as recommended by iSeg.
V. Implementation feasibility of AI-assisted segmentation.
OUTLINE:
Patients undergo CT with standard of care radiation planning as well as physician and AI-directed segmentation of the tumor on study. One to two weeks later, patients undergo stereotactic body radiation therapy (SBRT) over 1-2 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo additional CT throughout the study and may undergo positron emission tomography (PET)/CT as clinically indicated throughout the study.
After completion of study treatment, patients are followed up at 30 days, 3 months, 6 months, 9 months, and 12 months.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients of (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:
Exclusion Criteria:
Patients who are receiving any other concurrent agents or genotoxic chemotherapy for cancer treatment
Patients with a prior or concurrent 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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergo CT with standard of care radiation planning as well as physician and AI-directed segmentation of the tumor on study. One to two weeks later, patients undergo SBRT over 1-2 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo additional CT throughout the study and may undergo PET/CT as clinically indicated throughout the study.
Other: Artificial Intelligence-based Intervention · Other: Best Practice · Procedure: Computed Tomography · Procedure: Positron Emission Tomography · Other: Radiology, Treatment Planning · Radiation: Stereotactic Body Radiation Therapy · Other: Survey Administration
Undergo AI-directed segmentation of the tumor
Also known as: AI Intervention, AI-based Intervention
Undergo standard of care radiation planning
Also known as: standard of care, standard therapy
Undergo CT and/or PET/CT
Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography
Undergo PET/CT
Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT
Undergo physician segmentation of the tumor
Undergo SBRT
Also known as: SABR, SBRT, Stereotactic Ablative Body Radiation Therapy
Ancillary studies
Determination of lesion segmentation and accuracy
The Dice Similarity Coefficient (DSC) and the 95th percentile Hausdorff Distance (HD95) will be calculated for each gross tumor volume (GTV) lesion by comparing physician de novo contours (P) with artificial intelligence (AI) contours (A). A linear mixed-effects model will be used to estimate the mean DSC(P, A\*) across all lesions while adjusting for patient-level clustering. The model will produce an estimated marginal mean DSC, its 95% confidence interval, and the one-sided p-value for the pre-specified hypothesis test of whether the mean DSC exceeds a clinically acceptable threshold. HD95(P, A) will be summarized descriptively using means, medians, and interquartile ranges. Sensitivity analyses will be performed if DSC values deviate substantially from normality; in such cases, per-patient mean DSC values will be computed and tested against the 0.72 threshold using a one-sample t-test or Wilcoxon signed-rank test.
Time frame: Baseline
Overall contouring time
The primary workflow endpoint examines whether AI assistance reduces overall contouring time relative to de novo physician contouring. For each patient (and each lesion when distinct timing is recorded), the time required for physician de novo contouring (T\_P) and for physician review and modification of AI-generated contours (T\_\[A\^\* \]) will be compared. The primary analysis will use a paired t-test to estimate the mean absolute reduction in time and the corresponding percent reduction. If patients contribute multiple lesions with independently recorded times, a linear mixed-effects model with a patient-level random intercept will be used instead of a simple paired test. This model will estimate the mean difference in contouring time and the associated 95% confidence interval. Will test whether T\_P is greater than Atime, indicating a workflow efficiency gain attributable to AI guidance. Percent time reduction, defined as (T\_P- T\_(A\^\* )) / T\_P × 100%, will be summarized.
Time frame: Baseline
Evaluation of internal target volume (ITV) generation
Will evaluate ITV generation to characterize AI performance in motion-inclusive target delineation and to assess the clinical utility of AI-assisted respiratory motion integration. Geometric agreement between physician-derived and AI-assisted ITVs will be assessed using DSC, HD95, centroid displacement, contour volume differences, and voxel-wise edit maps. These analyses will characterize systematic differences in motion envelope definition, identify regions most frequently modified by physicians, and evaluate the impact of respiratory motion on AI-assisted target delineation.
Time frame: Baseline
Comparison of physician evaluation of contours versus AI only contours
For GTV, secondary segmentation analyses will include comparisons of physician de novo contours versus AI-only contours (P versus \[vs\] A), AI-only contours versus physician-modified AI contours (A vs A\*), and physician de novo contours versus physician-modified AI contours (P vs A\*). These comparisons will quantify both the magnitude and direction of physician edits and assess the extent to which AI-assisted contours converge toward physician-derived reference contours. For each lesion, DSC and HD95 will be summarized using descriptive statistics, and paired analyses (paired t-tests, non-parametric alternatives or mixed-effects models) will be used to compare contour sets.
Time frame: Baseline
Time to progression (Local control)
Will be estimated using the Kaplan-Meier method and reported as the proportion of patients alive without radiographic evidence of recurrence at the treated lesion.
Time frame: At 12 months
Local failure
Will be defined using standard institutional radiographic criteria.
Time frame: Up to 12 months
Progression-free survival (PFS)
Will be evaluated using Kaplan-Meier estimation. The 12-month PFS rate and associated confidence intervals will be reported. While not a powered analysis, exploratory associations between contour quality metrics (e.g., DSC, HD95, magnitude of edits) and PFS may be explored using Cox proportional hazards regression; these analyses will be considered hypothesis-generating.
Time frame: From completion of stereotactic body radiation therapy until progression, physician-assessed progression, initiation of subsequent anti-cancer therapy, or death from any cause, assessed up to 12 months
Changes in pulmonary function
Will compare Radiation Therapy Oncology Group Pulmonary Function Test Toxicity Scale scores obtained before stereotactic body radiation therapy and at 12 months post-treatment. Analyses will quantify shifts in toxicity grades, summarize the distribution of functional changes, and describe the incidence of clinically meaningful pulmonary decline. If sample size permits paired statistical testing, ordinal tests or non-parametric alternatives may be used, although primary interpretation will remain descriptive given the limited cohort size.
Time frame: Before stereotactic body radiation therapy to 12 months post-treatment
Incidence of adverse events
Toxicity will be summarized according to Common Terminology Criteria for Adverse Events version 6.0, with attention to overall incidence, attribution, severity, timing, and patterns of adverse events. The maximum toxicity grade per patient and the incidence of grade ≥ 3 toxicities will be reported. Tabulation of toxicity profiles will characterize the safety and tolerability of stereotactic body radiation therapy delivered using AI-assisted segmentation.
Time frame: Up to 12 months post-treatment
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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