NCT07895277Recruiting
Longitudinal AI-Assisted Management of Indeterminate Pulmonary Nodules
Study of Imaging Evolution of Pulmonary Nodules and Artificial Intelligence-Assisted Diagnostic and Management Strategies
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 6000 (estimated)
- First submitted
- 19 Oct 2026
- Start date
- 1 Jan 2025
- Primary completion date
- 1 Nov 2027
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Diseases
- Lung cancer
- NCT number
- NCT07895277
What you commit to
- Study type: Interventional
- Planned participants: 6000
- From 1 Jan 2025 to the primary completion date, 1 Nov 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- \- 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.
Who the study is looking for
- \- 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.
Age in the registry: 35 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Radiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.