68Ga-P16-093 and 18F-FDG PET/CT Imaging in the Same Group of Clear Cell Renal Cell Carcinoma Patients

Study Overview
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Brief Summary
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PSMA is highly expressed on the cell surface of the microvasculature of several solid tumors, including clear cell renal cell carcinoma (ccRCC). This makes it a potentially imaging target for the detection of ccRCC. This pilot study was designed to evaluate the diagnostic performance of 68Ga-P16-093, a novel radiopharmaceutical targeting PSMA, which was compared with 18F-FDG PET/CT in the same group of ccRCC patients.

Detailed Description
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Renal cell carcinoma (RCC) is the most common solid tumor within the kidney and accounts for approximately 3% of all malignancies in the world. Clear cell RCC (ccRCC) is the most common subtype and accounts for the majority of kidney cancer-related deaths. Importantly, pro-angiogenic factors (VEGF, PDGF) are strongly upregulated in clear cell RCC, leading to high vascularized tumors. Prostate-specific membrane antigen (PSMA), as known as folate hydrolase I or glutamate carboxypeptidase II, is overexpressed on the cells of prostatic adenocarcinoma. However, PSMA is also expressed by tumor cells or neovascular endothelial cells of various solid neoplasms, such as renal cell carcinoma. Therefore, PSMA may be an ideal target for the diagnosis of ccRCC. 68Ga-P16-093, a novel radiopharmaceutical targeting PSMA, with the urea fragment of a conjugate that employs the HBED-CC chelator for labeling with 68Ga(III). The HBED-based chelating ligand binds the 68Ga3+ ion with high affinity in a pseudo-octahedral N2O4 coordination sphere by its two phenolate O, two amino-acetate carboxylate O, and two amino N donor atoms. This pilot study was designed to evaluate the diagnostic performance of 68Ga-P16-093 in the same group of ccRCC patients, compared with 18F-FDG PET/CT.

Official Title
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A Pilot Comparison of 68Ga-P16-093 and 18F-FDG PET/CT Imaging in the Same Group of Clear Cell Renal Cell Carcinoma Patients

Conditions
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Clear Cell Renal Cell Carcinoma

Intervention / Treatment
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* Drug: 68Ga-P16-093
* Drug: 18F-FDG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with confirmed or suspected clear cell Renal cell carcinoma; 68Ga-P16-093 18F-FDG PET/CT within a week; signed written consent. Exclusion Criteria: pregnancy; breastfeeding; known allergy against PSMA; any medical condition that in the opinion of the investigator may significantly interfere with study compliance.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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-P16-093 and 18F-FDG PET/ CT scan<br>Within 1 week, each patient underwent PET/CT scan after intravenous administration of 68Ga-P16-093 and 18F-FDG, respectively. | Drug: 68Ga-P16-093<br>* Intravenous injection of 68Ga-P16-093 with a dosage of 1.8-2.2 MBq (0.05-0.06 mCi)/kg.<br>* Other names: 68Ga-P16-093 injection;Drug: 18F-FDG<br>* Intravenous injection of 18F-FDG with a dosage of 5.55 MBq (0.15 mCi)/kg.<br>* Other names: 18F-FDG injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performance | comparing the number of tumor detected by 68Ga-P16-093 and 18F-FDG PET/CT | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| standardized uptake value (SUV) of tumor | comparing the SUVmax of tumor derived from 68Ga-P16-093 and 18F-FDG PET/CT | through study completion, an average of 1 year |