Clinical trial NCT07026110: Clinical Application Study of PET/CT for Differential Diagnosis of Non-small Cell Lung Cancer
Official title: Clinical Application Study of PET/CT for Differential Diagnosis of Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Lung Diseases
Lung Neoplasms
Lung Cancer Metastatic
Lung Inflammation
Keywords: Trophoblast cell surface antigen 2 (Trop2)
Epithelial cell adhesion molecule(EpCAM)
ImmunoPET
Lung tumor
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2025-06-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Biodistribution-Standardized uptake value (SUV) of normal tissues and organs.
timeFrame: 1 day from injection of the tracers
measure: SUV of tumors
timeFrame: 1 day from injection of the tracers
measure: Radiation dosimetry of tissues/organs
timeFrame: 1 day from injection of the tracers
measure: Radiation dosimetry of tumors
timeFrame: 1 day from injection of the tracers
measure: Radiation dosimetry of whole-body
timeFrame: 1 day from injection of the tracers
measure: Diagnostic sensitivity
timeFrame: 30 days
measure: Diagnostic specificity
timeFrame: 30 days
measure: Accuracy
timeFrame: 30 days
measure: Positive Predictive Value (PPV)
timeFrame: 30 days
measure: Negative Predictive Value (NPV)
timeFrame: 30 days
Secondary outcomes:
measure: ImmunoPET/CT in altering initial staging for patients with lung tumors
timeFrame: 3-6 months
measure: ImmunoPET/CT for postoperative surveillance for patients with lung tumors
timeFrame: 3-6 months
measure: ImmunoPET/CT for restaging for patients with lung tumors
timeFrame: 3-6 months
measure: ImmunoPET/CT in evaluating treatment responses
timeFrame: 1-2years
measure: ImmunoPET/CT in identifying inflammation and tumors in the lungs
timeFrame: 1 day from injection of the tracers
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Study officials:
affiliation: Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
name: Weijun Wei
role: STUDY_CHAIR
References: