An interventional study of AI-Assisted Longitudinal CT Assessment and Pulmonary Nodule Management in Pulmonary Nodules and Lung Neoplasms, sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Recruiting at 1 site in China. Open to participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Not applicable, Interventional, and Health services research
Patients with indeterminate lung nodules often face a choice between continued CT surveillance and invasive investigation. This trial compares management with or without access to an AI report that matches nodules across real serial CT scans, measures change, and estimates validated malignancy or invasiveness risks. The principal question is whether offering the report reduces lung resections that yield benign pathology over 24 months. Diagnostic delay, cancer stage, treatment opportunity, complications, and longer-term cancer outcomes are also assessed.
This pragmatic superiority trial uses individual 1:1 randomization, concealed allocation, and blinded central outcome assessment. Eligible patients have persistent 6 to 30 mm nodules and at least two already available CT examinations. They are enrolled at an unresolved management decision before an invasive procedure or definitive treatment. A second CT must never be delayed or ordered solely to make an otherwise urgent case eligible.
Both arms receive structured longitudinal review, usual quantitative tools, the same nodule-management pathway, and the same appointment reminders. The intervention arm additionally receives the locked AI report. Clinicians retain responsibility for decisions and document patient preferences. Thus the comparison estimates the added effect of the AI-assisted strategy over an organized usual-care pathway, rather than over absent follow-up.
All randomized participants contribute to the primary analysis. Benign procedures are assessed per randomized patient rather than only among patients eventually classified as benign. This avoids making the primary denominator depend on postrandomization diagnostic work-up. Long-term surveillance also addresses the possibility that an apparent early reduction in surgery merely postpones diagnosis.
193 studies on the registry are indexed under Multiple Pulmonary Nodules; 60 are open to participants now.
This study's planned enrollment of 6,000 is above the median of 88 across 97 interventional studies indexed under Multiple Pulmonary Nodules.
Browse Multiple Pulmonary Nodules studies →Union Hospital, Tongji Medical College, Huazhong University of Science and Technology is the lead sponsor of 174 studies on the registry; 138 are open to participants now.
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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.
- 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.
Usual care plus the locked AI report reviewed with the actual CT images.
Device: AI-Assisted Longitudinal CT Assessment and Pulmonary Nodule Management
Serial CT comparison, clinical risk assessment, routine measurement tools, and guideline-based management without access to the trial AI report.
AI software analyzes serial clinically acquired chest CT scans to match pulmonary nodules, quantify changes in volume and solid components, and provide malignancy or invasiveness risk estimates. Intervention-arm clinicians review the AI report alongside CT images during management consultations. The baseline report is targeted within one working day after randomization. The same locked model is reapplied to clinically indicated follow-up CT scans during the 24-month intervention period. Clinicians retain responsibility for final decisions; AI findings cannot independently override clinically indicated evaluation. If processing fails or images are unsuitable, usual care proceeds. Both arms follow the same structured nodule-management pathway, but the control arm has no access to trial AI reports.
Lung Resection Yielding Benign Pathology Within 24 Months
Time frame: Randomization through month 24. Procedures performed in this window are included even if their final pathology report is completed shortly afterward.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Through controlled access under compatible consent and institutional authorization
Time frame: Begin 12 months after the primary publication and maintain access for at least five years. Release the later safety dataset after the corresponding analysis.
Access criteria: Qualified researchers submit a scientific proposal to the study committee; approved access requires a data-use agreement and institutional permission. No repository URL is asserted before one exists.
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 ↗
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology →