NCT07463300

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,500

participants targeted

Target at P75+ for all trials

Timeline
15mo left

Started Aug 2024

Typical duration for all trials

Geographic Reach
1 country

9 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Aug 2024Aug 2027

Study Start

First participant enrolled

August 1, 2024

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 11, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

3 years

First QC Date

March 6, 2026

Last Update Submit

March 6, 2026

Conditions

Lung Cancer

Keywords

subtypeartificial intelligencediagnosis

Outcome Measures

Primary Outcomes (1)

  • Accurate differentiation between small cell lung cancer and non-small cell lung cancer

    1 year

Secondary Outcomes (1)

  • Histological subtyping of NSCLC, including adenocarcinoma, squamous cell carcinoma, and other NSCLC subtypes

    1 year

Other Outcomes (1)

  • Accurate identification of EGFR gene mutation status

    1 year

Study Arms (4)

Training Cohort

All patients underwent pre-treatment 18F-FDG PET/CT scan.

Other: PET imaging analysis, data mining, and AI model developing

Validation Cohort

All patients underwent pre-treatment 18F-FDG PET/CT scan.

Other: PET imaging analysis, data mining, and AI model developing

Test cohort

All patients underwent pre-treatment 18F-FDG PET/CT scan.

Other: PET imaging analysis, data mining, and AI model developing

Prospective cohort

All patients underwent pre-treatment 18F-FDG PET/CT scan.

Other: PET imaging analysis, data mining, and AI model developing

Interventions

PET imaging analysis, data mining, and AI model developingOTHER

PET imaging analysis, data mining, and AI model developing

Prospective cohortTest cohortTraining CohortValidation Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The target population of this study is patients with lung cancer who have undergone pre-treatment 18F-FDG PET/CT. The study will assess the relationships between PET/CT-based imaging features and clinical variables with the pathological subtypes.

You may qualify if:

  • 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

You may not qualify if:

  • ▪ Pure ground-glass nodules with no FDG uptake

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Guangdong Second Provincial General Hospital

Guangzhou, Guangdong, 510403, China

RECRUITING

Wuhan Tongji Hospital

Wuhan, Hubei, 430030, China

RECRUITING

Zhongnan Hospital

Wuhan, Hubei, 430071, China

RECRUITING

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, 225001, China

RECRUITING

First Hospital of China Medical University

Shenyang, Liaoning, 110801, China

RECRUITING

West China Hospital

Chengdu, Sichuan, 610041, China

RECRUITING

The First Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310006, China

RECRUITING

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

Hangzhou, Zhejiang, 310009, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Lung NeoplasmsDisease

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Hong Zhang

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hong Zhang

CONTACT

0086-571-87767138hzhang21@zju.edu.cn

Xiaohui Zhang

CONTACT

0086-571-87767138zhanghui4127@zju.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2026

First Posted

March 11, 2026

Study Start

August 1, 2024

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

March 11, 2026

Record last verified: 2026-03

Locations

CN(9)