Clinical trial NCT06680089: CD70-targeted immunoPET Imaging of Kidney Cancer
Official title: A Study of the Clinical Application of [18F]RCCB6 PET/ CT Imaging in the Diagnosis of Kidney Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Urologic Neoplasms
Urogenital Neoplasms
Kidney Neoplasms
Neoplasms
Keywords: The cluster of differentiation (CD70)
Kidney tumor
Clear cell renal cell carcinoma
ImmunoPET
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2024-11-08
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Biodistribution of [18F]RCCB6
timeFrame: 1 day from injection of the tracer
measure: Standardized uptake value (SUV)
timeFrame: 1 day from injection of the tracer
measure: Radiation dosimetry of [18F]RCCB6
timeFrame: 1 day from injection of the tracer
measure: The correlation between CD70 expression and [18F]RCCB6 uptake value
timeFrame: 60 days
measure: Diagnostic value of [18F]RCCB6 PET/CT in patients with ccRCC
timeFrame: 30 days
Secondary outcomes:
measure: The predictive value of [18F]RCCB6 in the course of combined immunotherapies and targeted therapies
timeFrame: 3-6 months
measure: [18F]RCCB6 PET/CT in changing clinical decision-making for ccRCC patients
timeFrame: 3-6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
Study officials:
affiliation: Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
name: Wei Zhai, Ph.D. & M.D.
role: STUDY_CHAIR
affiliation: Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
name: Weijun Wei, Ph.D. & M.D.
role: PRINCIPAL_INVESTIGATOR
References: