NCT06843629Recruiting
Clinical Application of PET Imaging Targeting MSLN in Malignant Tumors
Source: ClinicalTrials.gov · Last updated 28 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 20 Dec 2024
- Start date
- 1 Oct 2024
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Diseases
- Lung cancer, Pancreatic cancer, Ovarian cancer
- NCT number
- NCT06843629
What you commit to
- Study type: Observational
- Planned participants: 100
- From 1 Oct 2024 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Wuhan Union Hospital, China Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
Related publications
- Immuno-PET imaging of mesothelin in ovarian cancer with 68Ga-XH04: a first-in-human study.Biomark Res · 2026 · PMID 42638115
This page is information, not medical advice. Discuss any trial with your doctor.