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.
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
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
300
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.
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.
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.
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.
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.
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, China
RECRUITINGThe uptake patterns of CD70-targeted tracers across different tumors
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.
Time frame: One month after the injection of the tracers
The diagnostic value of CD70-targeted immunoPET/CT across different tumors
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.
Time frame: One month from the injection of the tracers
The impact of CD70-targeted immunoPET/CT on clinical decision-making
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.
Time frame: 3-6 months after the injection of the tracers
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