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A Hierarchical Multi-modal AI Framework for Pathological and Genetic Subtyping of Lung Cancer Based on PET/CT Imaging

A Hierarchical Multi-modal AI Framework for Pathological and Genetic Subtyping of Lung Cancer Based on PET/CT Imaging

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07463300
Enrollment
5500
Registered
2026-03-11
Start date
2024-08-01
Completion date
2027-08-01
Last updated
2026-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

subtype, artificial intelligence, diagnosis

Brief summary

PET/CT imaging and clinical information (age, gender, smoking history, family history of cancer, history of present illness, and several tumor biomarkers, etc.) were used to establish a hierarchical multi-modal AI framework for pathological and genetic subtyping of lung cancer

Detailed description

The multi-modal AI framework is developed to facilitate a hierarchical and precise stratification process. The first level involves the accurate differentiation between small cell lung cancer and non-small cell lung cancer (NSCLC) in patients diagnosed with lung cancer. The second level entails the further categorization of NSCLC patients into adenocarcinoma, squamous cell carcinoma, and other less prevalent subtypes. The third level involves predicting the mutation status of the EGFR driver gene, which is most-commonly observed in patients with lung adenocarcinoma. The whole cohort was divided into the training cohort (retrospective), validation cohort (retrospective), test cohort (retrospective), and prospective cohort.

Interventions

OTHERPET imaging analysis, data mining, and AI model developing

PET imaging analysis, data mining, and AI model developing

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER
First Hospital of China Medical University
CollaboratorOTHER
West China Hospital
CollaboratorOTHER
Zhongnan Hospital
CollaboratorOTHER
Zhejiang Cancer Hospital
CollaboratorOTHER
Guangdong Second Provincial General Hospital
CollaboratorOTHER
The First Affiliated Hospital of Zhejiang Chinese Medical University
CollaboratorOTHER
Wuhan TongJi Hospital
CollaboratorOTHER
Northern Jiangsu People's Hospital
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Newly diagnosed NSCLC confirmed pathologically * Age ≥18 y * Underwent pre-treatment 18F-FDG PET/CT scan * No prior anti-tumor treatments * No history of other malignancies

Exclusion criteria

▪ Pure ground-glass nodules with no FDG uptake

Design outcomes

Primary

MeasureTime frame
Accurate differentiation between small cell lung cancer and non-small cell lung cancer1 year

Secondary

MeasureTime frame
Histological subtyping of NSCLC, including adenocarcinoma, squamous cell carcinoma, and other NSCLC subtypes1 year

Countries

China

Contacts

CONTACTHong Zhang
hzhang21@zju.edu.cn0086-571-87767138
CONTACTXiaohui Zhang
zhanghui4127@zju.edu.cn0086-571-87767138
PRINCIPAL_INVESTIGATORHong Zhang

Department of Nuclear Medicine and PET/CT Center, The Second Affiliated Hospital, School of Medicine, Zhejiang University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026