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NCT Number: NCT06852638

CD70-targeted immunoPET Imaging 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.

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Key information

Conditions

Renal Cancer Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Follicular Lymphoma Head and Neck Neoplasms Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Kidney Diseases Kidney Neoplasms Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Male Urogenital Diseases Mantle Cell Lymphoma Nasopharyngeal Carcinoma Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Renal Clear Cell Carcinoma Stomatognathic Diseases Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

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.

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 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.

Treatment and study plan

[18F]F-RESCA-RCCB6

Drug

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

[18F]F-RESCA-R8B4

Drug

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

[68Ga]Ga-NOTA-R8B4

Drug

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

[18F]F-RESCA-RD06

Drug

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.

[68Ga]Ga-NOTA-RD06

Drug

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

Study contacts

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

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

CONTACT

[email protected]

15000083153

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 28, 2025
Registry last updated
May 12, 2026

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.

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