CD70-targeted immunoPET Imaging of Kidney Cancer

Not Applicable

Recruiting

• Conditions: Urologic Neoplasms; Urogenital Neoplasms; Kidney Neoplasms; Neoplasms
• Interventions: Drug: [18F]RCCB6

• Registration Number: NCT06680089
• Lead Sponsor: RenJi Hospital

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. For clear cell renal cell carcinoma patients receiving systemic treatments, repeated CD70-targeted immunoPET imaging might be performed.

Enrolled patients will undergo whole-body \[18F\]RCCB6 immunoPET/CT scans at 1-2 hours 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. The correlation between lesion uptake and protein expression level determined by immunohistochemistry staining will be further analyzed. The exploration endpoint will be the imaging feasibility and preliminary diagnostic value of the above tracer.

Study Timeline

• Study Start: 2024-08-01
• Status Verified: 2024-11
• Study First Submitted: 2024-11-06
• Study First Submitted QC: 2024-11-06
• Study First Posted: 2024-11-08
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-22
• Primary Completion: 2026-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CD70-targeted immunoPET imaging	[18F]RCCB6	Enrolled patients will undergo a CD70-targeted immunoPET/CT scanning.

Primary Outcome Measures

Name	Time	Method
Biodistribution of [18F]RCCB6	1 day from injection of the tracer	Measurement of the overall biodistribution of \[18F\]RCCB6 in normal tissues and organs.
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.
Radiation dosimetry of [18F]RCCB6	1 day from injection of the tracer	Measurement of absorbed radiation doses (Gy/MBq) to tissues/organs, tumor(s), and whole body (Sv/MBq). Dynamic imaging within one hour will be acquired for the purpose.
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.
Diagnostic value of [18F]RCCB6 PET/CT 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.

Secondary Outcome Measures

Name	Time	Method
The predictive value of [18F]RCCB6 in the course of combined immunotherapies and targeted therapies	3-6 months	Baseline and follow-up \[18F\]RCCB6 immunoPET imaging in combined immunotherapies and targeted therapies (four to eight cycles) will be investigated in this setting to determine the value of \[18F\]RCCB6 immunoPET imaging in predicting or evaluating treatment responses.
[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.

Trial Locations

Locations (1)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University; 🇨🇳 Shanghai, Shanghai, China