Kidney Neoplasms, Neoplasms, Urogenital Neoplasms, Urologic Neoplasms
Conditions
Keywords
The cluster of differentiation (CD70), Kidney tumor, Clear cell renal cell carcinoma, ImmunoPET
Brief summary
The aim of this study is to establish and optimize the \[18F\]RCCB6 PET/CT imaging method, and its physiological and pathological distribution characteristics, on the basis of which the diagnostic efficacy of the above imaging agent in renal cancer (especially clear cell renal cell carcinoma) wil be evaluated.
Detailed description
Histologically confirmed diagnosis of kidney cancer (especially clear cell renal cell carcinoma and papillary renal cell carcinoma) or suspected kidney cancer by diagnostic imaging will be included. Especially patients with suspected metastases or routine follow-up or surveillance or suitable for systemic treatments (e.g., combined immunotherapy and targeted therapies) will undergo \[18F\]RCCB6 immunoPET/CT scans. Enrolled patients will undergo whole-body \[18F\]RCCB6 immunoPET/CT scans at 1 hour after tracer injection(0.05-0.1 mCi/kg). Uptake of \[18F\]RCCB6 in tumor and normal organs/tissues will be scored visually and quantitatively. Tumor uptake will be quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy will be calculated to evaluate the diagnostic efficacy. Furthermore, we will compare the diagnostic rates of \[18F\]RCCB6 immunoPET/CT with those of conventional imaging examinations, such as CT, MRI, and 18F-FDG PET/CT, etc.The correlation between lesion uptake and protein expression level determined by immunohistochemistry staining will be further analyzed. Further explore the value of \[18F\]RCCB6 in treatment decision-making（staging, surveillance, and restaging） for kidney cancer.We will conduct an interim assessment when more than half of the patients have been enrolled.
Interventions
DRUG[18F]RCCB6
Enrolled patients will receive 0.05-0.1mCi/kg of \[18F\]RCCB6. ImmunoPET/CT imaging will be acquired 1 hour after \[18F\]RCCB6 injection.
Sponsors
RenJi Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 18-80 year-old and of either sex； 2. Histologically confirmed diagnosis of kidney cancer (especially clear cell renal cell carcinoma and papillary renal cell carcinoma) or suspected kidney cancer by diagnostic imaging; 3. Capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol.
Exclusion criteria
1. Pregnancy； 2. Severe hepatic and renal insufficiency; 3. History of serious surgery in the last month; 4. Allergic to antibody or single-domain antibody radiopharmaceuticals.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Standardized uptake value (SUV) | 1 day from injection of the tracer | Standardized uptake value (SUV) of \[18F\]RCCB6 in the included subjects' primary and/or metastatic lesions. |
| The correlation between CD70 expression and [18F]RCCB6 uptake value | 60 days | The Standardized uptake value (SUV) of \[18F\]RCCB6 will be calculated, and the correlation between pathological results and tumor uptake of \[18F\]RCCB6 will be analyzed. |
| Biodistribution of [18F]RCCB6 | 1 day from injection of the tracer | Measurement of the overall biodistribution of \[18F\]RCCB6 in normal tissues and organs. |
| Diagnostic value of [18F]RCCB6 PET in patients with ccRCC | 30 days | We will calculate the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy of \[18F\]RCCB6 PET/CT in patients with ccRCC. We will also compare the diagnostic value of \[18F\]RCCB6 with that of traditional imaging tracers (e.g., 18F-FDG) and imaging modalities (e.g., CT and MRI). All the above goals will be achieved by analyzing the static/dynamic \[18F\]RCCB6 PET/CT imaging data. Systematic evaluation of these parameters will elucidate the pharmacokinetics, pharmacodynamics, and, more importantly, the clinical value of \[18F\]RCCB6 PET/CT for patients with ccRCC. |
| To explore the diagnostic performance of [18F]RCCB6 PET with that of conventional imaging and [18F]FDG PET | 6 months | Using pathological or follow-up imaging data as the gold standard, explore the diagnostic performance of \[18F\]RCCB6 PET compared to conventional imaging and \[18F\]FDG PET. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| [18F]RCCB6 PET/CT in changing clinical decision-making for ccRCC patients | 3-6 months | After analyzing the imaging parameters and diagnostic/predictive value of \[18F\]RCCB6 PET/CT, we will also investigate how clinical use of \[18F\]RCCB6 PET/CT changes clinical decision-making for ccRCC patients. Joint efforts from nuclear medicine physicians, urologists, oncologists, and pathologists will draw solid conclusions from the imaging and clinical information. |
Countries
China
Contacts
Primary ContactWeijun Wei, Ph.D. & M.D.
Backup ContactWei Zhai, Ph.D. & M.D.
Outcome results
None listed