Clinical trial NCT06715839: Target-specific immunoPET Imaging of Digestive System Carcinoma
Official title: Development and Clinical Translation of immunoPET Imaging Probes for Digestive System Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: 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
Keywords: human epidermal growth factor receptor 2 (HER2)
Trophoblast cell surface antigen 2 (TROP2)
Glypican-3 (GPC3)
Glycoprotein A33 (gpA33)
Nectin cell adhesion molecule-4 (Nectin-4)
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2024-12-04
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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 criteria: 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.

Primary outcomes:
measure: Biodistribution
timeFrame: 1 day from injection of the tracers
measure: Standardized uptake value (SUV)
timeFrame: 1 day from injection of the tracers
measure: Radiation dosimetry
timeFrame: 1 day from injection of the tracers
measure: Diagnostic value in patients with digestive system malignancy
timeFrame: 30 days
measure: The correlation between the expression of specific target and tracer uptake value
timeFrame: 60 days
Secondary outcomes:
measure: Predictive value of these tracers in the course of combined immunotherapies and targeted therapies
timeFrame: 3-6 months
measure: Target-specific PET/CT in changing clinical decision-making for patients with digestive system malignancy
timeFrame: 3-6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
Study officials:
affiliation: Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
name: Weijun Wei
role: STUDY_CHAIR
References: