Actively Recruiting
Clinical Application Study of PET/CT for Differential Diagnosis of Non-small Cell Lung Cancer
Led by RenJi Hospital · Updated on 2025-06-18
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of Trop2 and EpCAM-specific PET/CT imaging to noninvasively visualize the expression levels of these markers in patients with non-small cell lung cancer (NSCLC). The study aims to compare this novel targeted PET/CT imaging with conventional 18F-FDG PET/CT scans in diagnosing and differentiating solid lung nodules. The goal is to better understand the diagnostic value and imaging feasibility of these new tracers in NSCLC patients. Participants diagnosed with solid lung nodules suspected of NSCLC will undergo whole-body immunoPET/CT scans 1-2 hours after injection of one of several tracers ([68Ga]Ga-NOTA-T4, [68Ga]Ga-NOTA-RT4, [18F]F-RESCA-T4, [18F]F-RESCA-RT4, [18F]F-RESCA-EPCD6, or [68Ga]Ga-NOTA-EPCD6) at doses of 0.05-0.1 mCi/kg. The imaging results will be visually and quantitatively scored, including tumor uptake measured by maximum standardized uptake value (SUVmax). Patients will also have undergone 18F-FDG PET/CT and surgical resection or biopsy as per guidelines. During the study, tumor and normal tissue uptake, radiation dosimetry, and diagnostic accuracy including sensitivity and specificity will be assessed within 30 days. Additional follow-up over months to years will evaluate changes in staging, surveillance, restaging, and treatment responses using immunoPET/CT. Participants will be monitored through imaging and clinical assessments to understand tracer behavior and diagnostic performance in NSCLC.
CONDITIONS
Brief Title
Clinical Application Study of PET/CT for Differential Diagnosis of Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Imaging studies suspect non-small cell lung cancer
- Solid lung nodules 8 mm or larger diagnosed by chest CT
- Scheduled for 18F-FDG PET/CT and surgical resection or biopsy according to guidelines
- Patient or family has agreed and signed informed consent
You will not qualify if you...
- Women who are pregnant or breastfeeding
- History of surgery or trauma affecting metabolism or anatomy
- Severe systemic diseases or known allergy to humanized monoclonal antibody products
- Unable to cooperate with PET/CT examination
- Participation in other clinical studies with radiation exposure over 50 mSv in past year
- Investigator’s opinion that patient should not participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive an injection of a targeted tracer followed by a whole-body immunoPET/CT scan 1-2 hours later to assess lung nodules suspected of non-small cell lung cancer.
1 visit (in-person)
Duration - Up to 2 years
Participants are observed for diagnostic sensitivity, specificity, and accuracy of imaging, with additional immunoPET/CT scans used for initial staging, postoperative surveillance, restaging, and treatment response evaluation over time.
Follow-up visits as needed over 3-24 months
Trial Site Locations
Total: 1 location
1
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, China, 200127
Actively Recruiting
Research Team
W
Weijun Wei
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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