RecruitingNot ApplicableNCT06715839

Target-specific immunoPET Imaging of Digestive System Carcinoma

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

Sponsor

RenJi Hospital

Enrollment

400 participants

Start Date

Dec 4, 2024

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria3

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

Exclusion Criteria4

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

Interventions

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.