NCT06715839

Target-specific immunoPET Imaging of Digestive System Carcinoma

Development and Clinical Translation of immunoPET Imaging Probes for Digestive System Carcinoma

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	[68Ga]Ga-DOTA-H2D3	Enrolled patients (especially those with gastric cancer) will receive 0.05-0.1 mCi/kg of a HER2-targeted probe (\[68Ga\]Ga-DOTA-H2D3). ImmunoPET/CT imaging will be acquired 1-2 hours after \[68Ga\]Ga-DOTA-H2D3 injection.
DRUG	[18F]F-RESCA-RB14	Enrolled patients (especially those with gastric cancer) will receive 0.05-0.1 mCi/kg of a HER2-targeted probe (\[18F\]F-RESCA-RB14). ImmunoPET/CT imaging will be acquired 1-2 hours after \[18F\]F-RESCA-RB14 injection.
DRUG	[68Ga]Ga-NOTA-T4	Enrolled patients (especially those with gastric cancer/pancreatic cancer) will receive 0.05-0.1 mCi/kg of a Trop2-targeted probe (\[68Ga\]Ga-NOTA-T4). ImmunoPET/CT imaging will be acquired 1-2 hours after \[68Ga\]Ga-NOTA-T4 injection.
DRUG	[18F]F-RESCA-T4	Enrolled patients (especially those with gastric cancer/pancreatic cancer) will receive 0.05-0.1 mCi/kg of a Trop2-targeted probe (\[18F\]F-RESCA-T4). ImmunoPET/CT imaging will be acquired 1-2 hours after \[18F\]F-RESCA-T4 injection.
DRUG	[68Ga]Ga-NOTA-G5	Enrolled patients (especially those with hepatocellular carcinoma) will receive 0.05-0.1 mCi/kg of a GPC3-targeted probe (\[68Ga\]Ga-NOTA-G5). ImmunoPET/CT imaging will be acquired 1-2 hours after \[68Ga\]Ga-NOTA-G5 injection.
DRUG	[18F]F-RESCA-G5	Enrolled patients (especially those with hepatocellular carcinoma) will receive 0.05-0.1 mCi/kg of a GPC3-targeted probe (\[18F\]F-RESCA-G5). ImmunoPET/CT imaging will be acquired 1-2 hours after \[18F\]F-RESCA-G5 injection.
DRUG	[68Ga]Ga-NOTA-WWH347	Enrolled patients (especially those with colorectal cancer) will receive 0.05-0.1 mCi/kg of a GPA33-targeted probe (\[68Ga\]Ga-NOTA-WWH347). ImmunoPET/CT imaging will be acquired 1-2 hours after \[68Ga\]Ga-NOTA-WWH347 injection.
DRUG	[18F]F-RESCA-WWH347	Enrolled patients (especially those with colorectal cancer) will receive 0.05-0.1 mCi/kg of a GPA33-targeted probe (\[18F\]F-RESCA-WWH347). ImmunoPET/CT imaging will be acquired 1-2 hours after \[18F\]F-RESCA-WWH347 injection.
DRUG	[68Ga]Ga-NOTA-RND20	Enrolled patients will receive 0.05-0.1 mCi/kg of a Nectin-4-targeted probe (\[68Ga\]Ga-NOTA-RND20). ImmunoPET/CT imaging will be acquired 1-2 hours after \[68Ga\]Ga-NOTA-RND20 injection.
DRUG	[18F]F-RESCA-RND20	Enrolled patients will receive 0.05-0.1 mCi/kg of a Nectin-4-targeted probe (\[18F\]F-RESCA-RND20). ImmunoPET/CT imaging will be acquired 1-2 hours after \[18F\]F-RESCA-RND20 injection.

Timeline

• Start date: 2024-12-04
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2024-12-04
• Last updated: 2025-12-31

Locations

1 site across 1 country: China