Clinical trial · Observational
Clinical Application of PET Imaging Targeting MSLN in Malignant Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Adenocarcinoma | Lung Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Specific positron imaging agents targeting MSLN | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Visual and standardized uptake values assessment of lesions and biodistribution
- timeFrame
- 1 year
- description
- 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.
Secondary outcomes (2)
- measure
- Radioactivity in the blood and urine samples
- timeFrame
- 1 year
- description
- Blood samples were collected at 25 minutes, 55 minutes and 115 minutes after injection.
- measure
- Pathological sections of tumour tissue
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDDeng Y, Zhang X, Pan Z, Lv X, Lin Z, Feng Y, Wu Z, Song X, Gai Y, Yin H, Zhu J, Jiang D, Lan X. Immuno-PET imaging of mesothelin in ovarian cancer with 68Ga-XH04: a first-in-human study. Biomark Res. 2026 Aug 24;14(1):91. doi: 10.1186/s40364-026-00989-x. PMID 42638115