Clinical trialNARecruiting
Target-specific immunoPET Imaging of Digestive System Carcinoma
Development and Clinical Translation of immunoPET Imaging Probes for Digestive System Carcinoma
- Outcome
- Ongoing
- Phase
- NA
- Status
- Recruiting
- Study type
- Interventional
- Start
- 4 December 2024
- Expected end
- September 2027
- Enrollment
- 400 participants
- Sites
- 1
- Primary outcomes
- Biodistribution; Standardized uptake value (SUV); Radiation dosimetry; Diagnostic value in patients with digestive system malignancy; The correlation between the expression of specific target and tracer uptake value
- Sponsor
- Other
- Results posted
- No
- Last update
- 31 December 2025
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Brief summary public domain (ClinicalTrials.gov)
The aim of this study is to establish and optimize the target-specific PET/CT imaging method, and its physiological and pathological distribution characteristics, on the basis of which the diagnostic efficacy of the above imaging agents in digestive system malignant tumors will be evaluated.
Detailed description public domain (ClinicalTrials.gov)
Enrolled patients will undergo whole-body PET/CT scans at 1 hours after tracer injection(0.05-0.1 mCi/kg). Uptake of above imaging agents in tumor 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 evaluate the diagnostic efficacy. The correlation between lesion uptake and protein expression level determined by immunohistochemistry staining will be further analyzed. The exploration endpoint will be the imaging feasibility and preliminary diagnostic value of the above tracers.