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

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Lung Cancer Metastatic; Lung Neoplasms; Lung Diseases; Lung Inflammation; Lung Cancer

Treatments: Drug: [68Ga]Ga-NOTA-T4; Drug: [18F]F-RESCA-RT4; Drug: [68Ga]Ga-NOTA-RT4; Drug: [68Ga]Ga-NOTA-EPCD6; Drug: [18F]F-RESCA-T4; Drug: [18F]F-RESCA-EPCD6

Study type: Interventional

Funder types: Other

Identifiers

NCT07026110

LY2024-329-C

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

ImmunoPET imaging in patients with lung cancers

Experimental group

Description:

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

Treatment:

Drug: [18F]F-RESCA-EPCD6

Drug: [18F]F-RESCA-T4

Drug: [68Ga]Ga-NOTA-EPCD6

Drug: [68Ga]Ga-NOTA-RT4

Drug: [18F]F-RESCA-RT4

Drug: [68Ga]Ga-NOTA-T4