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Clinical Trial NCT07172503 for Colorectal Cancer, Gastric Cancer (GC), Pancreatic Cancer is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Clinical Application of PET Imaging Targeting GPA33 in Malignant Tumors 56

Not yet recruiting
Clinical Trial NCT07172503 is an interventional study for Colorectal Cancer, Gastric Cancer (GC), Pancreatic Cancer and is currently not yet recruiting. Enrollment is planned to begin on 1 October 2025 and continue until the study accrues 56 participants. Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, this study is expected to complete by 31 December 2026. The latest data from ClinicalTrials.gov was last updated on 15 September 2025.
Brief 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...Show More
Detailed Description
Malignant tumors are one of the major diseases leading to death worldwide, and their high incidence and mortality rates pose a serious threat to human health. According to the World Health Organization (WHO), there will be about 19.3 million new cancer cases and 10 million deaths globally in 2020, with a significant increase in the incidence of malignant tumors such as colorectal and gastric cancers in particular. Ea...Show More
Official Title

Clinical Application of PET Imaging Targeting GPA33 in Malignant Tumors

Conditions
Colorectal CancerGastric Cancer (GC)Pancreatic Cancer
Other Study IDs
  • XLan-0907
NCT ID Number
NCT07172503
Start Date (Actual)
2025-10-01
Last Update Posted
2025-09-15
Completion Date (Estimated)
2026-12-31
Enrollment (Estimated)
56
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Primary Purpose
Diagnostic
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalPET imaging targeting GPA33 in malignant tumors
Determine if targeting GPA33 PET is safe and effective method for imaging of malignant tumors.
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...Show More
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Visual and standardized uptake values assessment of lesions and biodistribution
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.
1 year
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Radioactivity in the blood and urine samples
Blood samples were collected at 25 minutes, 55 minutes and 115 minutes after injection.
1 year
Pathological sections of tumour tissue
The excised tumour tissue was taken for immunohistochemistry to verify its GPA33 expression
1 year
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes

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.

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.
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology logoUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study Central Contact
Contact: Xiaoli Lan, PhD, 0086-027-83692633, [email protected]
1 Study Locations in 1 Countries

Hubei

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, 430030, China
Xiaoli Lan, PhD, Contact, +86-027-83692633, [email protected]