CD70-targeted immunoPET Imaging of Malignant Cancers

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Nasopharyngeal Carcinoma; Renal Cancer; Renal Clear Cell Carcinoma; Mantle Cell Lymphoma; Follicular Lymphoma; Lymphoma, Large B-Cell, Diffuse; Lymphoma

Treatments: Drug: [89Zr]Zr-DFO-R8B4; Drug: [89Zr]Zr-DFO-RB6; Drug: [68Ga]Ga-NOTA-R8B4; Drug: [18F]F-RESCA-RCCB6; Drug: [18F]F-RESCA-RD06; Drug: [18F]F-RESCA-R8B4; Drug: [68Ga]Ga-NOTA-RD06; Drug: [89Zr]Zr-DFO-RD06

Study type: Interventional

Funder types: Other

Identifiers

NCT06852638

LY2024-306-A

Details and patient eligibility

About

This study aims to establish and optimize the cluster of differentiation (CD70)-targeted immuno-positron emission tomography/computed tomography (immunoPET/CT) imaging method and its physiological and pathological distribution characteristics, based on which the diagnostic efficacy of the above imaging agents in malignant cancers (renal cancer (especially clear cell renal cell carcinoma), lymphoma, or nasopharyngeal carcinoma (NPC)) will be evaluated.

Full description

Histologically confirmed malignant cancers (renal cancer (especially clear cell renal cell carcinoma), lymphoma, or nasopharyngeal carcinoma (NPC)), or patients with suspected maligant 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 treatment efficacy evaluation.

Enrolled patients will undergo whole-body immunoPET/CT scans 1-2 hours after tracer injection (0.05-0.1 mCi/kg). The uptake of imaging tracers in tumors 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 assess the diagnostic efficacy. The correlation between lesion uptake and CD70 expression level determined by immunohistochemistry staining will be further analyzed. The primary exploration endpoint will be the tracers' imaging feasibility and preliminary diagnostic value compared to conventional imaging approaches like 18F-FDG PET/CT.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

300 participants in 1 patient group

CD70-targeted immunoPET imaging

Experimental group

Description:

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

Treatment:

Drug: [89Zr]Zr-DFO-RD06

Drug: [68Ga]Ga-NOTA-RD06

Drug: [18F]F-RESCA-R8B4

Drug: [68Ga]Ga-NOTA-R8B4

Drug: [18F]F-RESCA-RD06

Drug: [18F]F-RESCA-RCCB6

Drug: [89Zr]Zr-DFO-R8B4

Drug: [89Zr]Zr-DFO-RB6