Clinical trial · Interventional
Clinical Application of PET Imaging Targeting Nectin-4 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)
This study is a diagnostic study. Patients and healthy volunteers with clinically suspected or confirmed urothelial carcinoma, breast cancer, lung carcinoma and other malignant tumors with high expression of Nectin-4 will be recruited for PET/MR or PET/CT imaging targeting a Nectin-4-specific probe (in the case of \[68Ga\]Ga-NOTA-Nectin-4 antibody fragment) , to observe the reaction of volunteers and patients after injection of drugs, to evaluate the pharmacokinetics in vivo and the efficacy of diagnosis and staging, and to perform PET imaging in patients with contraindications. General information on the subjects' vital signs, clinical data, blood routine, liver and kidney functions and other biochemical indicators and other imaging data were collected, and histopathology of biopsy or surgical specimens was used as the final diagnostic criterion.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Lung Carcinoma | Lung Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Urothelial Carcinoma | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-NOTA-Nectin-4 antibody fragment | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PET imaging targeting Nectin-4 in malignant tumors
- description
- Determine if targeting Nectin-4 PET is safe and effective method for imaging of malignant tumors.
- interventionNames
- Drug: 68Ga-NOTA-Nectin-4 antibody fragment
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 Nectin-4 nuclear probe by the tumor, which implies a greater threat of the tumor being malignant or higher stage.
Secondary outcomes (2)
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 urothelial carcinoma, breast cancer and lung carcinoma (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 Nectin-4 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 (0)
Data not yet available