Follicular Lymphoma, Lymphoma, Lymphoma, Large B-Cell, Diffuse, Mantle Cell Lymphoma, Nasopharyngeal Carcinoma, Renal Cancer, Renal Clear Cell Carcinoma
Conditions
Keywords
The cluster of differentiation (CD70), ImmunoPET, Renal Cancer, Lymphoma, Nasopharyngeal Carcinoma
Brief summary
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.
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.
Interventions
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.
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.
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.
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.
Sponsors
RenJi Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The uptake patterns of CD70-targeted tracers across different tumors | 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. |
| The diagnostic value of CD70-targeted immunoPET/CT across different tumors | 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
| Measure | Time frame | Description |
|---|---|---|
| The impact of CD70-targeted immunoPET/CT on clinical decision-making | 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. |
Countries
China
Contacts
CONTACTWeijun Wei, Ph.D. & M.D.
STUDY_CHAIRJianjun Liu, Ph.D. & M.D.
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
PRINCIPAL_INVESTIGATORWeijun Wei, Ph.D. & M.D.
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Outcome results
None listed