68Ga-N188 PET/CT Imaging in Malignancy

Study Overview
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Brief Summary
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The Nectin-4 protein belongs to the cell adhesion factors family and has a tissue-specific expression spectrum in normal human tissues. However, Nectin-4 is overexpressed in various malignancies, especially those of epithelial origins, such as uroepithelial carcinoma, making Nectin-4 a highly specific and significant imaging target for malignancies. [68Ga]N188, a novel molecular probe of PET imaging agent that targets Nectin-4, can be used in the diagnosis and research of a wide variety of Nectin-4 high-expression malignancies, including bladder cancer.

Official Title
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A Study to Evaluate 68Ga-N188 PET/CT Imaging of Nectin-4 Expression in Malignant Tumors

Conditions
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Neoplasms

Intervention / Treatment
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* Drug: [68Ga]N188


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with confirmed or suspected cancer; 18F-FDG PET/CT within 1 week; Signed written informed consent. Exclusion Criteria: Pregnant and lactating women; Female patients plan to become pregnant within 6 months.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [68Ga]N188<br>Subjects with suspected or confirmed malignancy will receive an intravenous injection of 68Ga-N188 followed by PET imaging. The subjects will also receive a whole-body 18F-FDG PET/CT scan within a one-week period. | Drug: [68Ga]N188<br>* 68Ga-N188 is injected intravenously with a dose of 0.06-0.08 mCi/kg.<br>* Other names: Nectin-4 specific PET imaging;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The diagnostic efficacy of 68Ga-N188 PET/CT in the evaluation of malignant tumors | Compare the standardized Uptake Value (SUV) of lesions on 68Ga-N188 and 18F-FDG PET/CT | 1 year | 
| The diagnostic efficacy of 68Ga-N188 PET/CT in the evaluation of malignant tumors | Compare the number of lesions detected by 68Ga-N188 and 18F-FDG PET/CT, based on the pathology or clinical follow-up as gold standard. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The dosimetry of 68Ga-N188 | Research on the dose distribution of 68Ga-N188 in healthy volunteers and cancer patients by 1-hour dynamic PET/CT acquisition and analyze by the dosimetry software | 1 year | 
| Quantitative evaluation of 68Ga-N188 | Evaluation of quantitative parameters of 68Ga-N188, such as time-activity curve. | 1 year | 
| Correlation with pathological expression | Analyze Nectin-4 expression at the imaging level in combination with Nectin-4 expression in pathological specimens | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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[68Ga]N188, Nectin-4, PET/CT, Neoplasms