Clinical Trial · NCT07172503

Clinical Application of PET Imaging Targeting GPA33 in Malignant Tumors

Overview

This study is a diagnostic study. Patients and healthy volunteers with clinically suspected or confirmed colorectal cancer, gastric cancer, pancreatic cancer and other malignant tumors with high expression of GPA33 will be recruited for PET/MR or PET/CT imaging targeting a GPA33-specific probe (in the case of \[68Ga\]Ga-NOTA-GPA33 nanobody) , to observe the reaction of volunteers and patients after injection of drugs, to evaluate the pharmacokinetics in vivo and the efficacy of diagnosis and staging, and to perform PET imaging in patients with contraindications. General information on the subjects' vital signs, clinical data, blood routine, liver and kidney functions and other biochemical indicators and other imaging data were collected, and histopathology of biopsy or surgical specimens was used as the final diagnostic criterion.

Sponsor

Norwegian University of Science and Technology

Phase

N/A

Contacts

Xiaoli Lan, PhD (CONTACT)

lxl730724@hotmail.com

0086-027-83692633

ClinicalTrials.gov

NCT07172503

Drug / Compound

GPA33 nanobody

Isotope(s):

Target(s):

GPA33

Ligand Class: Small Proteins and Antibody Fragments

Chelator: NOTA

Eligibility

Inclusion

6: Females of childbearing potential who have been using contraception for at least one month prior to screening and who are committed to using contraception for the entire study period and until a specified time after the end of the study；
Each subject must meet all enrollment criteria to be eligible to participate in the study:
2: A commitment to comply with the research procedures and to cooperate in the implementation of the full research process;
7: Other set entry criteria.
5: Consistent with the results of specific laboratory tests;
4: Patients with clinically suspected or confirmed malignant tumors such as colorectal cancer, gastric cancer, pancreatic cancer (supporting evidence includes serum-related tumor markers, imaging data such as ultrasound, CT, MRI, etc., and histological pathology examination, etc.) and in good general condition;

Exclusion

5: Patients considered by the investigator to have poor compliance;
2: Having other comorbidities;
3: Patients with known hypersensitivity to GPA33 nanobody developers or synthetic excipients; fasting blood glucose level greater than 11.0 mmol/L prior to 18F-FDG injection；
1: Those who are unable to complete a PET/MR or PET/CT examination (including inability to lie down, claustrophobia, radiophobia, etc.);
7: Persons with other factors that make participation in this test inappropriate.
All subjects who meet any of the exclusion criteria baseline will be excluded from the study:
6: Patients during pregnancy or lactation;
4: Have a history of comorbid drug use;