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Lung CarcinomaNCT07898241

Using an Artificial Intelligence Software Tool (iSeg) During Radiation Treatment Planning for Patients With Lung Tumors

A study testing Artificial Intelligence-based Intervention, Best Practice and Computed Tomography in people with Lung Carcinoma and Lung Non-Small Cell Carcinoma, run by Northwestern University at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Artificial Intelligence-based Intervention, Best Practice and Computed Tomography
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteUnited States
Study dates
13 Feb 2027to 13 Mar 2032
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 oligo-metastatic 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 Response Evaluation Criteria in Solid Tumors (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
  • For oligo-metastatic cancers, patients with oligo-persistent disease are excluded
  • Patients who have not recovered from adverse events confined to the thorax (i.e. pneumonitis, bronchial insufficiency, bronchial hemorrhage, esophagitis) due to prior anti-cancer therapy (i.e., have residual toxicities ≥ grade 2) with the exception of alopecia, skin toxicity, 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 in 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
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  • 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:
  • 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.

Study Coordinator contact

3126951301

cancer@northwestern.edu

United States1 site

  • Northwestern University

    Chicago, Illinois, 60611

    Mohamed E. Abazeed, MD, PhD, 312-503-2195, mabazeed@northwestern.edu

    Mohamed E. Abazeed, MD, PhD

Other trials in United States

About this study

Official title: A Single-Arm Phase II Study of AI-Guided Individualized Segmentation (iSeg) in Patients With Lung Tumors

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

  1. 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.

Being tested
Artificial Intelligence-based Intervention, Best Practice, Computed Tomography, Positron Emission Tomography, 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.

  • Artificial Intelligence-based InterventionOther

    Also called AI Intervention, AI-based Intervention

    Undergo AI-directed segmentation of the tumor

  • Best PracticeOther

    Also called standard of care, standard therapy

    Undergo standard of care radiation planning

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT and/or PET/CT

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET/CT

  • Radiology, Treatment PlanningOther

    Undergo physician segmentation of the tumor

  • Stereotactic Body Radiation TherapyRadiation

    Also called SABR, SBRT, Stereotactic Ablative Body Radiation Therapy

    Undergo SBRT

  • Survey AdministrationOther

    Ancillary studies

Study groups in NCT07898241
Study groupRoleWhat they receive
Treatment (iSeg, SBRT)ExperimentalPatients 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.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline

  2. 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.

    Measured: Baseline

Secondary outcomes (7)

  1. 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.

    Measured: Baseline

  2. 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.

    Measured: Baseline

  3. 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.

    Measured: At 12 months

  4. Local failure

    Will be defined using standard institutional radiographic criteria.

    Measured: Up to 12 months

  5. 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.

    Measured: 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

  6. 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.

    Measured: Before stereotactic body radiation therapy to 12 months post-treatment

  7. 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.

    Measured: Up to 12 months post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2026
  2. Study start13 Feb 2027 (estimated)
  3. Primary completion13 Feb 2030 (estimated)
  4. Study completion13 Mar 2032 (estimated)

Resources

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
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07898241
Sponsor's protocol ID
NU 26L01
Other IDs
NCI-2026-06803, STU00226892, NU 26L01, P30CA060553
Status last verified
Oct 2026
First submitted
13 Oct 2026
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Artificial Intelligence-based Intervention, Best Practice and Computed 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 14 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: opening soon, as of the sponsor's last update on 27 Oct 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?

Determination of lesion segmentation and accuracy (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07898241.

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 27 Oct 2026.

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