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Target-specific immunoPET Imaging of Digestive System Carcinoma

Target-specific immunoPET Imaging of Digestive System Carcinoma

Recruiting
18-75 years
All
Phase N/A

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Overview

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.

Description

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.

Eligibility

Inclusion Criteria:

  1. Aged 18-75 years old and of either sex;
  2. Histologically confirmed diagnosis of digestive system carcinoma or suspected digestive system carcinoma by diagnostic imaging;
  3. Capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol.

Exclusion Criteria:

  1. Pregnancy;
  2. Severe hepatic and renal insufficiency;
  3. History of serious surgery in the last month;
  4. Allergic to antibody or single-domain antibody radiopharmaceuticals.

Study details
    Malignancy
    Digestive Cancer
    Digestive System Neoplasm
    Digestive System Carcinoma
    Digestive System Cancer
    Liver Cancer
    Stomach Cancer
    Colon Cancer
    Rectum Cancer
    Pancreatic Cancer
    Esophagus Cancer
    Gallbladder Carcinoma
    Small Intestine Cancer
    Appendix Cancer
    Bile Duct Carcinoma

NCT06715839

RenJi Hospital

3 September 2025

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