CD70-targeted immunoPET Imaging of Malignant Cancers

Not Applicable

Recruiting

• Conditions: Renal Cancer; Renal Clear Cell Carcinoma; Lymphoma; Lymphoma, Large B-Cell, Diffuse; Follicular Lymphoma; Mantle Cell Lymphoma; Nasopharyngeal Carcinoma
• Interventions: Drug: [18F]F-RESCA-RCCB6; Drug: [18F]F-RESCA-R8B4; Drug: [18F]F-RESCA-RD06; Drug: [68Ga]Ga-NOTA-R8B4; Drug: [68Ga]Ga-NOTA-RD06; Drug: [89Zr]Zr-DFO-RB6; Drug: [89Zr]Zr-DFO-R8B4; Drug: [89Zr]Zr-DFO-RD06

• Registration Number: NCT06852638
• Lead Sponsor: RenJi Hospital

Brief 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.

Study Timeline

• Study Start: 2024-12-23
• Status Verified: 2025-02
• Study First Submitted: 2025-02-16
• Study First Submitted QC: 2025-02-24
• Last Update Submitted: 2025-02-24
• Study First Posted: 2025-02-28
• Last Update Posted: 2025-02-28
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CD70-targeted immunoPET imaging	[18F]F-RESCA-RCCB6	Enrolled patients will undergo a CD70-targeted immunoPET/CT scanning.
CD70-targeted immunoPET imaging	[18F]F-RESCA-R8B4	Enrolled patients will undergo a CD70-targeted immunoPET/CT scanning.
CD70-targeted immunoPET imaging	[18F]F-RESCA-RD06	Enrolled patients will undergo a CD70-targeted immunoPET/CT scanning.
CD70-targeted immunoPET imaging	[68Ga]Ga-NOTA-R8B4	Enrolled patients will undergo a CD70-targeted immunoPET/CT scanning.
CD70-targeted immunoPET imaging	[68Ga]Ga-NOTA-RD06	Enrolled patients will undergo a CD70-targeted immunoPET/CT scanning.
CD70-targeted immunoPET imaging	[89Zr]Zr-DFO-RB6	Enrolled patients will undergo a CD70-targeted immunoPET/CT scanning.
CD70-targeted immunoPET imaging	[89Zr]Zr-DFO-R8B4	Enrolled patients will undergo a CD70-targeted immunoPET/CT scanning.
CD70-targeted immunoPET imaging	[89Zr]Zr-DFO-RD06	Enrolled patients will undergo a CD70-targeted immunoPET/CT scanning.

Primary Outcome Measures

Name	Time	Method
Standardized uptake value (SUV) of normal tissues and organs.	1 day from injection of the tracers	Measurement of the overall biodistribution of the above tracers in normal tissues and organs (bladder (after voiding), background (pelvic fat), blood, brain, salivary and lacrimal glands, lung, liver, spleen, pancreas, small intestine, and kidneys). To calculate the SUV, circular regions of interest were drawn around the area of focally increased uptake in the transaxial slices and automatically fitted to a three-dimensional volume of interest.
SUV of tumors	1 day from injection of the tracers	The SUV of the above tracers in the primary and/or metastatic lesions of the included subjects. To calculate the SUV, circular regions of interest were drawn around the area of focally increased uptake in the transaxial slices and automatically fitted to a three-dimensional volume of interest.
Radiation dosimetry of tissues/organs	1 day from injection of the tracers	Measurement of absorbed radiation doses (Gy/MBq) to tissues/organs. The following tissues were included: adrenals, brain, breasts, gallbladder, small intestine, upper and lower large intestine, stomach, heart contents, heart muscle, kidney, liver, lung, muscle, ovaries, pancreas, red marrow, trabecular and cortical bone, spleen, testes, thymus, thyroid, urinary bladder, and uterus. Dynamic imaging within one hour will be performed for this purpose.
Radiation dosimetry of tumors	1 day from injection of the tracers	Measurement of absorbed radiation doses (Gy/MBq) to tumors. Dynamic imaging within one hour will be performed for this purpose.
Radiation dosimetry of whole-body	1 day from injection of the tracers	Whole-body activity was measured using a large volume of interest (VOI) covering the entire subject.
Diagnostic sensitivity	30 days	Sensitivity = (True Positives) / (True Positives + False Negatives). The diagnostic value of CD70 immunoPET/CT will be compared with that of conventional imaging approaches, including 18F-FDG PET/CT, CT, and MRI.
Diagnostic specificity	30 days	Specificity = (True Negatives) / (True Negatives + False Positives). The diagnostic value of CD70 immunoPET/CT will be compared with that of conventional imaging approaches, including 18F-FDG PET/CT, CT, and MRI.
Accuracy	30 days	Accuracy = (True Positives + True Negatives) / (Total Tests). The diagnostic value of CD70 immunoPET/CT will be compared with that of conventional imaging approaches, including 18F-FDG PET/CT, CT, and MRI.
Positive Predictive Value (PPV)	30 days	PPV = (True Positives) / (True Positives + False Positives). The diagnostic value of CD70 immunoPET/CT will be compared with that of conventional imaging approaches, including 18F-FDG PET/CT, CT, and MRI.
Negative Predictive Value (NPV)	30 days	NPV = (True Negatives) / (True Negatives + False Negatives). The diagnostic value of CD70 immunoPET/CT will be compared with that of conventional imaging approaches, including 18F-FDG PET/CT, CT, and MRI.

Secondary Outcome Measures

Name	Time	Method
CD70 immunoPET/CT in altering initial staging for patients with renal cancer/lymphoma/NPC	3-6 months	Assess the role of CD70 immunoPET/CT in initial staging in terms of the number of metastases.
CD70 immunoPET/CT for postoperative surveillance for patients with renal cancer/lymphoma/NPC	3-6 months	Assess the role of CD70 immunoPET/CT in surveillance in terms of the number of metastases, CD70-derived tumor volume (CD70-TV), and total lesion CD70 uptake (CD70-TLU).
CD70 immunoPET/CT for restaging for patients with renal cancer/lymphoma/NPC	3-6 months	Assess the role of CD70 immunoPET/CT in restaging in terms of the number of metastases, CD70-TV, and CD70-TLU.
CD70 immunoPET/CT in evaluating treatment responses	1-2 years	We will also investigate the role of CD70 immunoPET/CT in predicting and evaluating the treatment efficacy in patients with renal cancer (especially clear cell renal cell carcinoma, ccRCC), lymphoma, or NPC. The treatment regimens vary for different tumor types but involve chemotherapy, molecularly targeted therapies, immunotherapies (e.g. PD-1/PD-L1 inhibitors), or cell therapies.

Trial Locations

Locations (1)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University; 🇨🇳 Shanghai, China