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

NCT ID: NCT07026110

Last Updated: 2025-06-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-23
• Study Completion Date: 2026-10-31

Brief Summary

This study aims to explore the efficacy of Trop2, EpCAM-specific PET/CT imaging for noninvasive visualization of Trop2 or EpCAM expression levels in non-small cell lung cancer; and to explore the differences between novel target-specific PET/CT examinations and conventional 18F-FDG PET/CT in the diagnosis and differential diagnosis of solid lung nodules.

Detailed Description

A solid lung nodule was initially diagnosed as non-small cell lung cancer by chest CT. Patients with lung nodules subjected to 18F-FDG PET/CT with surgical resection/biopsy. Patients will also be included for routine follow-up, surveillance, and treatment efficacy evaluation.Enrolled patients will undergo whole-body immunoPET/CT scans 1-2 hours after tracer injection (0.05-0.1 mCi/kg). The uptake of imaging tracers in tumors and normal organs/tissues will be scored visually and quantitatively.Tumor uptake will be quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy will be calculated to assess the diagnostic efficacy. The correlation between lesion uptake and Trop2 and EpCAM expression level determined by immunohistochemistry staining will be further analyzed. The primary exploration endpoint will be the tracers' imaging feasibility and preliminary diagnostic value compared to conventional imaging approaches like 18F-FDG PET/CT.

Conditions

Lung Cancer; Lung Diseases; Lung Neoplasms; Lung Cancer Metastatic; Lung Inflammation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

ImmunoPET imaging in patients with lung cancers

Enrolled lung cancer patients will undergo a Trop2/EpCAM-targeted immunoPET/CT scanning.

Group Type: EXPERIMENTAL

[68Ga]Ga-NOTA-T4

Intervention Type: DRUG

Enrolled patients will receive 0.05-0.1 mCi/kg of \[68Ga\]Ga-NOTA-T4. ImmunoPET/CT imaging will be acquired 1-2 hours after \[68Ga\]Ga-NOTA-T4 injection.

[68Ga]Ga-NOTA-RT4

Intervention Type: DRUG

Enrolled patients will receive 0.05-0.1 mCi/kg of \[68Ga\]Ga-NOTA-RT4. ImmunoPET/CT imaging will be acquired 1-2 hours after \[68Ga\]Ga-NOTA-RT4 injection.

[18F]F-RESCA-T4

Intervention Type: DRUG

Enrolled patients will receive 0.05-0.1 mCi/kg of \[18F\]F-RESCA-T4. ImmunoPET/CT imaging will be acquired 1-2 hours after \[18F\]F-RESCA-T4 injection.

[18F]F-RESCA-RT4

Intervention Type: DRUG

Enrolled patients will receive 0.05-0.1 mCi/kg of \[18F\]F-RESCA-RT4. ImmunoPET/CT imaging will be acquired 1-2 hours after \[18F\]F-RESCA-RT4 injection.

[18F]F-RESCA-EPCD6

Intervention Type: DRUG

Enrolled patients will receive 0.05-0.1 mCi/kg of \[18F\]F-RESCA-EPCD6. ImmunoPET/CT imaging will be acquired 1-2 hours after \[18F\]F-RESCA-EPCD6 injection.

[68Ga]Ga-NOTA-EPCD6

Intervention Type: DRUG

Enrolled patients will receive 0.05-0.1 mCi/kg of \[68Ga\]Ga-NOTA-EPCD6. ImmunoPET/CT imaging will be acquired 1-2 hours after \[68Ga\]Ga-NOTA-EPCD6 injection.

Interventions

[68Ga]Ga-NOTA-T4

Enrolled patients will receive 0.05-0.1 mCi/kg of \[68Ga\]Ga-NOTA-T4. ImmunoPET/CT imaging will be acquired 1-2 hours after \[68Ga\]Ga-NOTA-T4 injection.

Intervention Type: DRUG

[68Ga]Ga-NOTA-RT4

Enrolled patients will receive 0.05-0.1 mCi/kg of \[68Ga\]Ga-NOTA-RT4. ImmunoPET/CT imaging will be acquired 1-2 hours after \[68Ga\]Ga-NOTA-RT4 injection.

Intervention Type: DRUG

[18F]F-RESCA-T4

Enrolled patients will receive 0.05-0.1 mCi/kg of \[18F\]F-RESCA-T4. ImmunoPET/CT imaging will be acquired 1-2 hours after \[18F\]F-RESCA-T4 injection.

Intervention Type: DRUG

[18F]F-RESCA-RT4

Enrolled patients will receive 0.05-0.1 mCi/kg of \[18F\]F-RESCA-RT4. ImmunoPET/CT imaging will be acquired 1-2 hours after \[18F\]F-RESCA-RT4 injection.

Intervention Type: DRUG

[18F]F-RESCA-EPCD6

Enrolled patients will receive 0.05-0.1 mCi/kg of \[18F\]F-RESCA-EPCD6. ImmunoPET/CT imaging will be acquired 1-2 hours after \[18F\]F-RESCA-EPCD6 injection.

Intervention Type: DRUG

[68Ga]Ga-NOTA-EPCD6

Enrolled patients will receive 0.05-0.1 mCi/kg of \[68Ga\]Ga-NOTA-EPCD6. ImmunoPET/CT imaging will be acquired 1-2 hours after \[68Ga\]Ga-NOTA-EPCD6 injection.

Intervention Type: DRUG

Other Intervention Names

[68Ga]T4; [68Ga]RT4; [18F]T4; [18F]RT4; [18F]F-EPCD6; [18F]F-EPCD6

Eligibility Criteria

Inclusion Criteria

1. Age 18-80 years;

2. Imaging studies suspecting non-small cell lung cancer;

3. Solid lung nodules (≥8 mm in diameter) diagnosed by chest ct, which are subject to 18F-FDG PET/CT and surgical resection/biopsy of lung nodules according to the NCCN guideline specifications for NSCLC in the 2024 edition;

4. Patients or family members agreed to participate in this clinical study and signed an informed consent form.

Exclusion Criteria

1. Women during pregnancy and lactation;

2. Persons with a history of surgery and trauma that significantly affects metabolic distribution and anatomical structure;

3. Persons with severe other systemic diseases or known hypersensitivity to humanized monoclonal antibody products;

4. Patient is unable to cooperate in completing the PET/CT examination;

5. Patient has participated in other clinical studies within the past year that have resulted in radiation exposures in excess of an effective dose of 50 mSv, in addition to the radiation exposures anticipated from participation in this clinical study;

6. Patient should not participate in this clinical trial in the opinion of the investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Weijun Wei

Role: STUDY_CHAIR

Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Locations

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Weijun Wei

Role: CONTACT

wwei@shsmu.edu.cn

15000083153

Facility Contacts

Weijun Wei

Role: primary

wwei@shsmu.edu.cn

15000083153

Wenzhi Jia

Role: backup

jwzdata@126.com

18317076979

Other Identifiers

LY2024-329-C

Identifier Type: -

Identifier Source: org_study_id