Clinical Application of PET Imaging Targeting MSLN in Malignant Tumors
Recruiting · NCT06843629 · Observational (researchers observe without assigning treatment) · Lead sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- Each subject must meet all enrollment criteria to be eligible to participate in the study:
- The subject or his/her legal representative is able to sign and date the informed consent form;
- A commitment to comply with the research procedures and to cooperate in the implementation of the full research process;
- Adult patients or healthy volunteers (aged 18 or above) of either sex;
- 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;
- Consistent with the results of specific laboratory tests;
- 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；
- Other set entry criteria.
Exclusion criteria
- All subjects who meet any of the exclusion criteria baseline will be excluded from the study:
- Those who are unable to complete a PET/MR or PET/CT examination (including inability to lie down, claustrophobia, radiophobia, etc.);
- Having other comorbidities;
- 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；
- Have a history of comorbid drug use;
- Patients considered by the investigator to have poor compliance;
- Patients during pregnancy or lactation;
- Persons with other factors that make participation in this test inappropriate.
Where it is running
1 location listed.
- Wuhan Union Hospital, China - Wuhan, Hubei, China