Trop2- and EpCAM-targeted PET/CT to help distinguish non-small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.