CD70-targeted immunoPET Imaging of Malignant Cancers

May 7, 2026 updated by: RenJi Hospital

CD70-targeted PET/ CT in the Diagnosis of Malignant Cancers

This study aims to determine the value of cluster of differentiation (CD70)-targeted immuno-positron emission tomography/computed tomography (immunoPET/CT) imaging for diagnosing human malignancies, including renal cell carcinoma (particularly clear cell renal cell carcinoma), lymphoma, and nasopharyngeal carcinoma (NPC), among others.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Histologically confirmed malignant cancers (renal cancer (especially clear cell renal cell carcinoma), lymphoma, or nasopharyngeal carcinoma (NPC)) or patients with suspected malignant cancers (renal cancer (especially clear cell renal cell carcinoma), lymphoma, or nasopharyngeal carcinoma (NPC)) indicated by conventional diagnostic imaging will be included. Patients will also be included for routine follow-up, surveillance, and evaluation of treatment efficacy following the initial CD70-targeted immunoPET/CT imaging.

Enrolled patients will undergo whole-body immunoPET/CT scans 1-2 hours after tracer injection (0.01-0.1 mCi/kg). Uptake of imaging tracers in tumors and normal organs/tissues will be scored both visually and quantitatively.

Tumor uptake will be quantified using the maximum standard uptake value (SUVmax). Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy will be calculated to assess diagnostic efficacy. The correlation between lesion uptake and CD70 expression levels, as determined by immunohistochemical staining, will be further analyzed. The primary exploratory endpoint will be the imaging feasibility of the tracers and their preliminary diagnostic value compared with conventional imaging approaches such as 18F-FDG PET/CT, CT/MRI. The secondary endpoint is the impact of CD70-targeted immunoPET/CT imaging on clinical decision-making.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China, 200127
        • Recruiting
        • Renji Hospital, School of Medicine, Shanghai Jiao Tong University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged 18-80 year-old and of either sex；
  • Histologically confirmed diagnosis of renal cancer (especially ccRCC)/lymphoma/NPC or suspected renal cancer/lymphoma/NPC by diagnostic imaging;
  • Capable of giving signed informed consent, including compliance with the requirements and restrictions in the informed consent form (ICF) and this protocol.

Exclusion Criteria:

  • Pregnancy；
  • Severe hepatic and renal insufficiency;
  • Allergic to single-domain antibody radiopharmaceuticals.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CD70-targeted immunoPET imaging
Enrolled patients will undergo a CD70-targeted immunoPET/CT scanning.
Drug: [18F]F-RESCA-RCCB6
Enrolled patients will receive 0.01-0.1 mCi/kg of [18F]RCCB6. ImmunoPET/CT imaging will be acquired 1-2 hours after [18F]RCCB6 injection.
Other Names:
  • [18F]RCCB6
Drug: [18F]F-RESCA-R8B4
Enrolled patients will receive 0.01-0.1 mCi/kg of [18F]R8B4. ImmunoPET/CT imaging will be acquired 1-2 hours after [18F]R8B4 injection.
Other Names:
  • [18F]R8B4
Drug: [68Ga]Ga-NOTA-R8B4
Enrolled patients will receive 0.01-0.1 mCi/kg of [68Ga]R8B4. ImmunoPET/CT imaging will be acquired 1-2 hours after [68Ga]R8B4 injection.
Other Names:
  • [68Ga]R8B4
Drug: [18F]F-RESCA-RD06
Enrolled patients will receive 0.01-0.1 mCi/kg of [18F]F-RESCA-RD06. ImmunoPET/CT imaging will be acquired 1-2 hours after [18F]F-RESCA-RD06 injection.
Drug: [68Ga]Ga-NOTA-RD06
Enrolled patients will receive 0.01-0.1 mCi/kg of [68Ga]Ga-NOTA-RD06. ImmunoPET/CT imaging will be acquired 1-2 hours after [68Ga]Ga-NOTA-RD06 injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The uptake patterns of CD70-targeted tracers across different tumors
Time Frame: One month after the injection of the tracers
Because the expression level of CD70 varies across tumors, including renal cell carcinoma (especially clear cell renal cell carcinoma), nasopharyngeal carcinoma, and lymphoma, due to different regulatory pathways, this variation will lead to differential uptake of CD70 tracers in these tumors. Therefore, the primary goal of the prospective study is to determine the uptake and distribution patterns of CD70-targeted tracers in patients with renal cell carcinoma (particularly clear cell), nasopharyngeal carcinoma, or lymphoma. To achieve this, imaging tracer uptake in tumors and normal organs/tissues will be scored both visually and quantitatively. Uptake will be correlated with CD70 expression determined by immunohistochemical staining.
One month after the injection of the tracers
The diagnostic value of CD70-targeted immunoPET/CT across different tumors
Time Frame: One month from the injection of the tracers
The primary outcome of the prospective study is to determine the diagnostic value of CD70-targeted immunoPET/CT in human malignancies, especially renal cell carcinoma (with a focus on clear cell renal cell carcinoma), lymphoma, and nasopharyngeal carcinoma. To achieve this, tumor uptake will be quantified using the maximum standard uptake value (SUVmax). sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy will be calculated to assess diagnostic efficacy. The correlation between lesion uptake and CD70 expression levels, as determined by immunohistochemical staining, will be further analyzed. The comparative diagnostic value of CD70-targeted immunoPET/CT, relative to traditional imaging approaches such as 18F-FDG PET/CT and CT/MRI, will be assessed in selected patients.
One month from the injection of the tracers

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The impact of CD70-targeted immunoPET/CT on clinical decision-making
Time Frame: 3-6 months after the injection of the tracers
The secondary outcome of the study is to determine the impact of CD70-targeted immunoPET/CT on clinical decision-making, especially for patients with clear cell renal cell carcinoma.
3-6 months after the injection of the tracers

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Investigators

  • Principal Investigator: Weijun Wei, Ph.D. & M.D., Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
  • Study Chair: Jianjun Liu, Ph.D. & M.D., Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 23, 2024

Primary Completion (Estimated)

December 23, 2026

Study Completion (Estimated)

December 23, 2026

Study Registration Dates

First Submitted

February 16, 2025

First Submitted That Met QC Criteria

February 24, 2025

First Posted (Actual)

February 28, 2025

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LY2024-306-A

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lymphoma

Clinical Trials on [18F]F-RESCA-RCCB6

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe