AI-assisted longitudinal CT to guide indeterminate lung nodules

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pragmatic, randomized study compares standard care with and without an AI-derived report that links nodules across multiple CT scans to estimate change and validated malignancy risk. Participants have persistent nodules between 6 and 30 mm and at least two prior CT exams, and they are enrolled at a decision point before invasive procedures. Clinicians remain responsible for decisions, while the AI report is available only in the intervention arm. The primary goal is to see if AI-assisted management reduces benign resections over 24 months, with additional assessment of diagnostic delay, cancer stage, treatment opportunities, and long-term outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

\- 1. At least one persistent indeterminate pulmonary nodule measuring 6 to 30 mm on the latest clinically obtained CT; solid, part-solid, and pure ground-glass nodules are eligible. 2. Two CT examinations in total are already available: the latest within 30 days before randomization and an earlier examination 3 to 24 months before it. Both meet the frozen image-quality requirements for longitudinal comparison. 3. The current decision between continued surveillance and further investigation remains unresolved, with no mandatory urgent procedure or committed definitive treatment before randomization.

4\. The patient is potentially eligible for curative treatment if cancer is diagnosed, with an estimated life expectancy of at least five years independent of the study nodule. 5. Written informed consent and willingness to permit record retrieval and five-year contact.

Exclusion Criteria:

\- 1.Definitive diagnosis or previous treatment of the target nodule; overt metastatic disease, suspicious adenopathy requiring urgent work-up, or another indication making delayed evaluation inappropriate. 2.Active malignancy or cancer treatment within the preceding five years, except definitively treated nonmelanoma skin cancer or in situ cervical cancer.

3\. Clinically important immunocompromise or active pulmonary infection requiring a separate diagnostic pathway. 4. Current participation in an organized lung-cancer screening program with a mandated management pathway incompatible with this trial. 5. CT quality or acquisition differences prevent valid longitudinal evaluation; a clearly benign lesion does not require a diagnostic management decision. 6. Known pregnancy; a conflicting interventional trial; prior randomization in this study; or consent cannot be obtained.

Where it's running

• Department of Radiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  Wuhan, Hubei, China Recruiting

Study contacts

• Study coordinator: Xiaoyu Han
• Email: xiaoyuhan1123@163.com
• Phone: +86 18202771604

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.