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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CD70-targeted immunoPET imaging | Experimental | Enrolled patients will undergo a CD70-targeted immunoPET/CT scanning. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The 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. | 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. | One month from the injection of the tracers |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3-6 months after the injection of the tracers |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weijun Wei, Ph.D. & M.D. | Contact | 15000083153 | wwei@shsmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jianjun Liu, Ph.D. & M.D. | Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University | Study Chair |
| Weijun Wei, Ph.D. & M.D. | Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital, School of Medicine, Shanghai Jiao Tong University | Recruiting | Shanghai | 200127 | China |
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| [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. |
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| [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. |
|
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| [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. |
|
| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| D002292 | Carcinoma, Renal Cell |
| D008223 | Lymphoma |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008224 | Lymphoma, Follicular |
| D020522 | Lymphoma, Mantle-Cell |
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D009303 | Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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