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Recruiting NCT06680089

CD70-targeted immunoPET Imaging of Kidney Cancer

Phase II Interventional Urologic Neoplasms Urogenital Neoplasms Kidney Neoplasms Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: [18F]RCCB6.
Who it may be relevant to
Registry conditions: Urologic Neoplasms, Urogenital Neoplasms, Kidney Neoplasms, Neoplasms. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Study of the Clinical Application of [18F]RCCB6 PET/ CT Imaging in the Diagnosis of Kidney Cancer

Overview

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.

Primary outcome measures

  • Biodistribution of [18F]RCCB6 [Time frame: 1 day from injection of the tracer]
  • Standardized uptake value (SUV) [Time frame: 1 day from injection of the tracer]
  • The correlation between CD70 expression and [18F]RCCB6 uptake value [Time frame: 60 days]
  • Diagnostic value of [18F]RCCB6 PET in patients with ccRCC [Time frame: 30 days]
  • To explore the diagnostic performance of [18F]RCCB6 PET with that of conventional imaging and [18F]FDG PET [Time frame: 6 months]
Secondary outcome measures (1)
  • [18F]RCCB6 PET/CT in changing clinical decision-making for ccRCC patients [Time frame: 3-6 months]

Eligibility criteria

Inclusion criteria

  • Aged 18-80 year-old and of either sex；
  • Histologically confirmed diagnosis of kidney cancer (especially clear cell renal cell carcinoma and papillary renal cell carcinoma) or suspected kidney cancer by diagnostic imaging;
  • 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

  • Pregnancy；
  • Severe hepatic and renal insufficiency;
  • History of serious surgery in the last month;
  • Allergic to antibody or single-domain antibody radiopharmaceuticals.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

China · 1 center
  • Renji Hospital, School of Medicine, Shanghai Jiao Tong University — Shanghai

Identifiers

NCT: NCT06680089 · LY2024-138-A

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗