Trials / Recruiting

RecruitingNCT06852638

CD70-targeted immunoPET Imaging of Malignant Cancers

A Study of the Clinical Application of CD70-targeted PET/ CT Imaging in the Diagnosis of Malignant Cancers

Status: Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 300 (estimated)

Sponsor: RenJi Hospital · Academic / Other
Sex: All
Age: 18 Years – 80 Years
Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

Interventions

Type	Name	Description
DRUG	[18F]F-RESCA-RCCB6	Enrolled patients will receive 0.05-0.1 mCi/kg of \[18F\]RCCB6. ImmunoPET/CT imaging will be acquired 1-2 hours after \[18F\]RCCB6 injection.
DRUG	[18F]F-RESCA-R8B4	Enrolled patients will receive 0.05-0.1 mCi/kg of \[18F\]R8B4. ImmunoPET/CT imaging will be acquired 1-2 hours after \[18F\]R8B4 injection.
DRUG	[18F]F-RESCA-RD06	Enrolled patients will receive 0.05-0.1 mCi/kg of \[18F\]RD06. ImmunoPET/CT imaging will be acquired 1-2 hours after \[18F\]RD06 injection.
DRUG	[68Ga]Ga-NOTA-R8B4	Enrolled patients will receive 0.05-0.1 mCi/kg of \[68Ga\]R8B4. ImmunoPET/CT imaging will be acquired 1-2 hours after \[68Ga\]R8B4 injection.
DRUG	[68Ga]Ga-NOTA-RD06	Enrolled patients will receive 0.05-0.1 mCi/kg of \[68Ga\]RD06. ImmunoPET/CT imaging will be acquired 1-2 hours after \[68Ga\]RD06 injection.
DRUG	[89Zr]Zr-DFO-RB6	Enrolled patients will receive a single dose (1-3 mCi) of \[89Zr\]Zr-DFO-RB6 (total 1-2 mg antibody mass). Multiple immunoPET/CT imaging sessions will be performed on day 0, day 1(24 h), day 3 (72 h), day 5 (120 h) or day 7 (168 h).
DRUG	[89Zr]Zr-DFO-R8B4	Enrolled patients will receive a single dose (1-3 mCi) of \[89Zr\]Zr-DFO-R8B4 (total 1-2 mg antibody mass). Multiple immunoPET/CT imaging sessions will be performed on day 0, day 1(24 h), day 3 (72 h), day 5 (120 h) or day 7 (168 h).
DRUG	[89Zr]Zr-DFO-RD06	Enrolled patients will receive a single dose (1-3 mCi) of \[89Zr\]Zr-DFO-RD06 (total 1-2 mg antibody mass). Multiple immunoPET/CT imaging sessions will be performed on day 0, day 1(24 h), day 3 (72 h), day 5 (120 h) or day 7 (168 h).

Timeline

Start date: 2024-12-23
Primary completion: 2026-12-01
Completion: 2026-12-01
First posted: 2025-02-28
Last updated: 2025-02-28

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT06852638. Inclusion in this directory is not an endorsement.