Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Phase
Observational
Started
2024-10-01
Last updated
2026-05-28
Condition(s) studied
Ovarian CancerLung AdenocarcinomaPancreatic Cancer
Investigational drug(s) / intervention(s)
Specific positron imaging agents targeting MSLN
Specific positron imaging agents targeting MSLN: To perform integrated PET/MR or PET/CT visualization of patients with clinically suspected or confirmed pancreatic cancer, ovarian cancer, lung adenocarcinoma and other malignant tumors with high MSLN expression and healthy volunteers, using specific positron imaging agents targeting MSLN (taking \[68Ga\]Ga-NOTA-MSLN antibody fragment as an example), 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
The project aims to perform integrated PET/MR or PET/CT visualization of patients with clinically suspected or confirmed pancreatic cancer, ovarian cancer, lung adenocarcinoma and other malignant tumors with high MSLN expression and healthy volunteers, using targeted MSLN-specific imaging agents (taking \[68Ga\]Ga-NOTA-MSLN antibody fragment as an example), 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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 pancreatic cancer, ovarian cancer, or lung adenocarcinoma (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 MSLN antibody fragment 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 MSLN 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
Wuhan Union Hospital, China
Wuhan
Hubei
Recruiting
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.
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