Trop2- and EpCAM-targeted PET/CT to help distinguish non-small cell lung cancer
Clinical Application Study of PET/CT for Differential Diagnosis of Non-small Cell Lung Cancer
This project will test whether PET/CT scans that target Trop2 and EpCAM can show protein expression in tumors of people with suspected non-small cell lung cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | RenJi Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT07026110 on ClinicalTrials.gov |
What this trial studies
Adults with solid lung nodules (≥8 mm) who are scheduled for standard 18F-FDG PET/CT and biopsy or surgical resection will be enrolled. Participants will receive one of several radiolabeled immunoPET tracers and undergo whole-body PET/CT 1–2 hours after injection, with tracer uptake scored visually and quantified by SUVmax. Diagnostic performance (sensitivity, specificity, PPV, NPV, accuracy) of the target-specific PET/CT will be compared head-to-head with conventional 18F-FDG PET/CT. Tracer uptake in lesions will be correlated with Trop2 and EpCAM expression measured by immunohistochemistry on resected or biopsied tissue to determine feasibility and preliminary diagnostic value.
Who should consider this trial
Good fit: Adults aged 18–80 with solid lung nodules ≥8 mm suspected for non-small cell lung cancer who are scheduled for 18F-FDG PET/CT and for biopsy or surgical resection and can give informed consent.
Not a fit: Pregnant or breastfeeding people, those unable to complete PET/CT, patients with severe comorbidities or known hypersensitivity to humanized monoclonal antibodies, and those not undergoing tissue confirmation are unlikely to benefit from this imaging-focused protocol.
Why it matters
Potential benefit: If successful, these targeted PET/CT scans could noninvasively reveal Trop2/EpCAM expression in lung nodules, improving diagnostic accuracy and helping guide biopsy or treatment decisions.
How similar studies have performed: Early immunoPET work targeting tumor surface markers including EpCAM and Trop2 has shown promising tumor uptake in preclinical and initial clinical work, but direct comparisons with 18F-FDG in NSCLC remain limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai
- Renji Hospital, School of Medicine, Shanghai Jiao Tong University — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Weijun Wei
- Email: wwei@shsmu.edu.cn
- Phone: 15000083153
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.