Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Phase
Not applicable
Started
2025-10-01
Last updated
2025-09-15
Condition(s) studied
Colorectal CancerGastric Cancer (GC)Pancreatic Cancer
Investigational drug(s) / intervention(s)
68Ga-NOTA-GPA33 nanobody
68Ga-NOTA-GPA33 nanobody: To perform integrated PET/MR or PET/CT visualization of patients with clinically suspected or confirmed colorectal cancer, gastric cancer, pancreatic cancer and other malignant tumors with high GPA33 expression and healthy volunteers, using specific positron imaging agents target GPA33(in the case of \[68Ga\]Ga-NOTA-GPA33 nanobody) , to achieve the following purposes: Patients with malignant tumors: for diagnosis and staging of diseases, comparing with the gold standard pathological diagnosis, evaluating diagnostic efficacy, clarifying the presence or absence of lesions, and determining the location and nature of lesions; comparing with \[18F\]FDG PET for accurate staging, evaluating the tumor load, and helping to determine the therapeutic plan. Healthy volunteers: Pharmacokinetic analysis will be performed to clarify the distribution and metabolism of the drug in the body and its safety.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
Accepted
Inclusion Criteria:
Each subject must meet all enrollment criteria to be eligible to participate in the study:
* 1: The subject or his/her legal representative is able to sign and date the informed consent form;
* 2: A commitment to comply with the research procedures and to cooperate in the implementation of the full research process;
* 3: Adult patients or healthy volunteers (aged 18 or above) of either sex;
* 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;
* 5: Consistent with the results of specific laboratory tests;
* 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；
* 7: Other set entry criteria.
Exclusion Criteria:
All subjects who meet any of the exclusion criteria baseline will be excluded from the study:
* 1: Those who are unable to complete a PET/MR or PET/CT examination (including inability to lie down, claustrophobia, radiophobia, etc.);
* 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；
* 4: Have a history of comorbid drug use;
* 5: Patients considered by the investigator to have poor compliance;
* 6: Patients during pregnancy or lactation;
* 7: Persons with other factors that make participation in this test inappropriate.
Primary outcome measure(s)
Visual and standardized uptake values assessment of lesions and biodistribution — 1 year At least two experienced nuclear medicine physicians will conduct a visual analysis using consensus reading. The standardized uptake value (SUV) of tumor and organs will be measured after a semiquantitative analysis is conducted for each case. The SUV ranges from 0 to infinity, and a higher score means a higher uptake of targeting GPA33 nuclear probe by the tumor, which implies a greater threat of the tumor being malignant or higher stage.
Trial sites (1)
Facility
City
Region
Status
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Hubei
More Union Hospital, Tongji Medical College, Huazhong University of Science and Technology trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.