Clinical trial NCT06852638: CD70-targeted immunoPET Imaging of Malignant Cancers
Official title: A Study of the Clinical Application of CD70-targeted PET/ CT Imaging in the Diagnosis of Malignant Cancers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Renal Cancer
Renal Clear Cell Carcinoma
Lymphoma
Lymphoma, Large B-Cell, Diffuse
Follicular Lymphoma
Mantle Cell Lymphoma
Nasopharyngeal Carcinoma
Keywords: The cluster of differentiation (CD70)
ImmunoPET
Renal Cancer
Lymphoma
Nasopharyngeal Carcinoma
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Standardized uptake value (SUV) of normal tissues and organs.
timeFrame: 1 day from injection of the tracers
measure: SUV of tumors
timeFrame: 1 day from injection of the tracers
measure: Radiation dosimetry of tissues/organs
timeFrame: 1 day from injection of the tracers
measure: Radiation dosimetry of tumors
timeFrame: 1 day from injection of the tracers
measure: Radiation dosimetry of whole-body
timeFrame: 1 day from injection of the tracers
measure: Diagnostic sensitivity
timeFrame: 30 days
measure: Diagnostic specificity
timeFrame: 30 days
measure: Accuracy
timeFrame: 30 days
measure: Positive Predictive Value (PPV)
timeFrame: 30 days
measure: Negative Predictive Value (NPV)
timeFrame: 30 days
Secondary outcomes:
measure: CD70 immunoPET/CT in altering initial staging for patients with renal cancer/lymphoma/NPC
timeFrame: 3-6 months
measure: CD70 immunoPET/CT for postoperative surveillance for patients with renal cancer/lymphoma/NPC
timeFrame: 3-6 months
measure: CD70 immunoPET/CT for restaging for patients with renal cancer/lymphoma/NPC
timeFrame: 3-6 months
measure: CD70 immunoPET/CT in evaluating treatment responses
timeFrame: 1-2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Study officials:
affiliation: Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
name: Jianjun Liu, Ph.D. & M.D.
role: STUDY_CHAIR
affiliation: Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
name: Weijun Wei, Ph.D. & M.D.
role: PRINCIPAL_INVESTIGATOR
References: