Target-specific immunoPET Imaging of Digestive System Carcinoma

Shanghai Jiao Tong University

Status: Enrolling

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

Treatments: Drug: [18F]F-RESCA-RB14; Drug: [68Ga]Ga-NOTA-T4; Drug: [18F]F-RESCA-WWH347; Drug: [68Ga]Ga-NOTA-G5; Drug: [68Ga]Ga-NOTA-WWH347; Drug: [18F]F-RESCA-T4; Drug: [68Ga]Ga-DOTA-H2D3; Drug: [18F]F-RESCA-RND20; Drug: [68Ga]Ga-NOTA-RND20; Drug: [18F]F-RESCA-G5

Study type: Interventional

Funder types: Other

Identifiers

NCT06715839

KY2024-107-C

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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400 participants in 1 patient group

ImmunoPET imaging in patients with digestive system carcinoma

Experimental group

Description:

Enrolled patients will undergo a targeted-specific immunoPET/CT scanning.

Treatment:

Drug: [18F]F-RESCA-G5

Drug: [18F]F-RESCA-RND20

Drug: [68Ga]Ga-NOTA-RND20

Drug: [68Ga]Ga-DOTA-H2D3

Drug: [18F]F-RESCA-T4

Drug: [68Ga]Ga-NOTA-WWH347

Drug: [68Ga]Ga-NOTA-G5

Drug: [18F]F-RESCA-WWH347

Drug: [68Ga]Ga-NOTA-T4

Drug: [18F]F-RESCA-RB14