Not Yet RecruitingNot applicableNCT07898241
Official study title

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

Study 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. 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedArtificial Intelligence-based Intervention and Best Practice

Plus 5 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 27, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Not Yet Recruiting

The study is not accepting participants yet.

What kind of study?Not applicable

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Northwestern University

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Not applicable
Sponsor
Northwestern University
Interventions being studied
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
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • 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:
  • 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
Reasons someone may not be able to joinExclusion criteria
  • 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
  • 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Northwestern UniversityChicago, Illinois

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 27, 2026. Always confirm current availability with the study team.

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