CD70-targeted immunoPET Imaging of Kidney Cancer

NCT06680089 | Recruiting Phase 2

• 1 other identifier: LY2024-138-A
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Urogenital Neoplasms; Kidney Neoplasms; Neoplasms; Urologic Neoplasms

Keywords

The cluster of differentiation (CD70); Kidney tumor; Clear cell renal cell carcinoma; ImmunoPET

Outcome Measures

Primary Outcomes (5)

• Biodistribution of [18F]RCCB6

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

  1 day from injection of the tracer

• Standardized uptake value (SUV)

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

  1 day from injection of the tracer

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

  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.

  60 days

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

  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.

  30 days

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

  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.

  6 months

Secondary Outcomes (1)

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

  3-6 months

Study Arms (1)

CD70-targeted immunoPET imaging

EXPERIMENTAL

Enrolled patients will undergo a CD70-targeted immunoPET/CT scanning.

Drug: [18F]RCCB6

Interventions

[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.

Also known as: [18F]F-RESCA-RCCB6

CD70-targeted immunoPET imaging

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Conditions

Urologic Neoplasms; Urogenital Neoplasms; Kidney Neoplasms; Neoplasms; Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

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

Study Officials

• Wei Zhai, Ph.D. & M.D.

  Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

  STUDY CHAIR

• Weijun Wei, Ph.D. & M.D.

  Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

15000083153; wwei@shsmu.edu.cn

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

CONTACT

18701771959; jacky_zw2002@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 8, 2024
• Study Start: November 27, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

CN (1)