Actively Recruiting
Clinical Application of PET Imaging Targeting MSLN in Malignant Tumors
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2026-05-28
100
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of integrated PET/MR or PET/CT imaging with targeted MSLN-specific agents to study patients who have or are suspected to have pancreatic cancer, ovarian cancer, lung adenocarcinoma, and other malignant tumors that show high expression of mesothelin (MSLN). The goal is to improve diagnosis, staging, and assessment of tumor burden by comparing this method with current standards like pathological diagnosis and \[18F\]FDG PET scans. The study also involves healthy volunteers to understand the drug's behavior and safety in the body. The study uses specific positron imaging agents targeting MSLN, such as the \[68Ga\]Ga-NOTA-MSLN antibody fragment, to visualize tumors and their characteristics. Patients undergo PET/MR or PET/CT scans for diagnosis and staging, while healthy volunteers receive the imaging agent for pharmacokinetic analysis to examine distribution, metabolism, and safety. This approach aims to clarify lesion presence, location, and nature, and to help guide therapeutic decisions. Participants will be involved in imaging procedures and monitored through visual and quantitative assessments of lesions and drug biodistribution over a one-year period. Blood and urine samples will be collected to measure radioactivity, and tumor tissue pathology will be reviewed. The study includes safety monitoring and pharmacokinetic evaluations to determine drug metabolism. The total duration of participant involvement is one year, with assessments designed to evaluate diagnostic performance and drug behavior in both patients and healthy individuals.
CONDITIONS
Brief Title
Clinical Application of PET Imaging Targeting MSLN in Malignant Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to sign informed consent
- Commitment to comply with research procedures
- Adults aged 18 or older, any gender
- Patients with suspected or confirmed pancreatic, ovarian, or lung adenocarcinoma tumors with supporting clinical evidence
- Good general health condition
- Meet specific laboratory test results
- Females of childbearing potential must use contraception before and during the study
- Other criteria as specified
You will not qualify if you...
- Unable to complete PET/MR or PET/CT scans (e.g., cannot lie down, claustrophobia)
- Having other significant medical conditions
- Known allergy to MSLN antibody fragments or related substances
- Fasting blood glucose above 11.0 mmol/L before [18F]FDG injection
- History of taking certain drugs affecting the study
- Poor compliance as determined by investigator
- Pregnant or breastfeeding women
- Any other factors making participation inappropriate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants undergo integrated PET/MR or PET/CT scans using specific positron imaging agents targeting MSLN to detect and stage malignant tumors or for pharmacokinetic analysis in healthy volunteers.
1 to 2 imaging visits depending on participant group
Duration - Up to 1 year
Participants are monitored for visual and standardized uptake values assessment, radioactivity in blood and urine samples, and pathological evaluation of tumor tissue as applicable.
Periodic sample collections and assessments during follow-up
Trial Site Locations
Total: 1 location
1
Wuhan Union Hospital, China
Wuhan, Hubei, China, 430030
Actively Recruiting
Research Team
X
Xiaoli Lan, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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