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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

Inclusion 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 Exclusion 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

Study sites (1)

IL