Longitudinal AI-Assisted Management of Indeterminate Pulmonary Nodules

NCT07895277 · tracked via the Priya Life Science China tracker

Sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Phase

Not applicable

Started

2025-01-01

Last updated

2026-10-26

Condition(s) studied

Pulmonary NodulesLung Neoplasms

Investigational drug(s) / intervention(s)

AI-Assisted Longitudinal CT Assessment and Pulmonary Nodule Management

AI-Assisted Longitudinal CT Assessment and Pulmonary Nodule Management: 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.

Study summary

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.

Eligibility

Sex

ALL

Min age

35 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Lung Resection Yielding Benign Pathology Within 24 Months — Randomization through month 24. Procedures performed in this window are included even if their final pathology report is completed shortly afterward.

Trial sites (1)

Facility	City	Region	Status
Department of Radiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei	Recruiting

More Union Hospital, Tongji Medical College, Huazhong University of Science and Technology trials in China

Clinical Trial of the Safety and Efficacy of Peripheral Nerve Stimulation in the Treatment of Peripheral Neuropathic Pain. Recruiting

Clinical Effectiveness of CEM in Diagnosis of Additional Findings at Preoperative Breast Magnetic Resonance Imaging Starting soon

Efficacy and Safety of Retlirafusp Alfa Plus Bevacizumab and Chemotherapy With or Without Short-Course Radiotherapy in Patients With CRCLM Recruiting

Deep Learning-Based Multidimensional Body Composition Mapping for Outcome Prediction in HCC Patients Undergoing TACE Recruiting

Dalpiciclib Combined With Aromatase Inhibitors and Olmesartan as the First-line Treatment for HR+/HER2- Advanced Breast Cancer Recruiting

Other trials for the same condition

Association of Psychological Distress in Patients With Lung Cancer Recruiting

Comparative Study of Rotational Cryobiopsy Needle and Automated Biopsy Needle in Transthoracic Biopsy Diagnosing Peripheral Pulmonary Lesions Enrolling by invitation

Intraoperative Longitude-Latitude-Depth Localization Versus Preoperative CT-Guided Percutaneous Lung Puncture Localization for 0.8-2 cm Peripheral Pulmonary Nodules Recruiting

Clinical Application Study of PET/CT for Differential Diagnosis of Non-small Cell Lung Cancer Recruiting

Comparison of Segmentectomy Versus Lobectomy for Non-small Cell Lung Cancer ≤ 2 cm in the Middle Third of the Lung Field Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07895277 on ClinicalTrials.gov ↗ ← All trials in China