Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06680089

CD70-targeted immunoPET Imaging of Kidney Cancer

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Urologic Neoplasms Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

[18F]RCCB6

Drug

Enrolled patients will receive 0.05-0.1mCi/kg of [18F]RCCB6. ImmunoPET/CT imaging will be acquired 1 hour after [18F]RCCB6 injection.

Other names: [18F]F-RESCA-RCCB6

Primary outcomes

  1. Biodistribution of [18F]RCCB6

    Time frame: 1 day from injection of the tracer

    Measurement of the overall biodistribution of [18F]RCCB6 in normal tissues and organs.

  2. Standardized uptake value (SUV)

    Time frame: 1 day from injection of the tracer

    Standardized uptake value (SUV) of [18F]RCCB6 in the included subjects' primary and/or metastatic lesions.

  3. The correlation between CD70 expression and [18F]RCCB6 uptake value

    Time frame: 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.

  4. Diagnostic value of [18F]RCCB6 PET in patients with ccRCC

    Time frame: 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.

  5. To explore the diagnostic performance of [18F]RCCB6 PET with that of conventional imaging and [18F]FDG PET

    Time frame: 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 outcomes

  1. [18F]RCCB6 PET/CT in changing clinical decision-making for ccRCC patients

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Wei Zhai, Ph.D. & M.D.

CONTACT

[email protected]

18701771959

Weijun Wei, Ph.D. & M.D.

CONTACT

[email protected]

15000083153

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Nov 8, 2024
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.