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CD70-targeted immunoPET Imaging of Kidney Cancer

ConditionsUrologic NeoplasmsUrogenital NeoplasmsKidney NeoplasmsNeoplasms
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorRenJi Hospital

About this trial

The aim of this study is to establish and optimize the \[18F\]RCCB6 PET/CT imaging method, and its physiological and pathological distribution characteristics, on the basis of which the diagnostic efficacy of the above imaging agent in renal cancer (especially clear cell renal cell carcinoma) wil be evaluated.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18-80 year-old and of either sex；

Histologically confirmed diagnosis of kidney cancer (especially clear cell renal cell carcinoma and papillary renal cell carcinoma) or suspected kidney cancer by diagnostic imaging;

Capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol.

Disqualifiers

Pregnancy；

Severe hepatic and renal insufficiency;

History of serious surgery in the last month;

Allergic to antibody or single-domain antibody radiopharmaceuticals.

Trial design

Design model

Single group

Treatments tested in this trial

  • [18F]RCCB6

    Drug

    Enrolled patients will receive 0.05-0.1mCi/kg of \[18F\]RCCB6. ImmunoPET/CT imaging will be acquired 1 hour after \[18F\]RCCB6 injection.

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: CD70-targeted immunoPET imagingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Biodistribution of [18F]RCCB6

Measurement of the overall biodistribution of \[18F\]RCCB6 in normal tissues and organs.

Time frame
1 day from injection of the tracer
2

Standardized uptake value (SUV)

Standardized uptake value (SUV) of \[18F\]RCCB6 in the included subjects' primary and/or metastatic lesions.

Time frame
1 day from injection of the tracer
3

The correlation between CD70 expression and [18F]RCCB6 uptake value

The Standardized uptake value (SUV) of \[18F\]RCCB6 will be calculated, and the correlation between pathological results and tumor uptake of \[18F\]RCCB6 will be analyzed.

Time frame
60 days
4

Diagnostic value of [18F]RCCB6 PET in patients with ccRCC

We will calculate the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy of \[18F\]RCCB6 PET/CT in patients with ccRCC. We will also compare the diagnostic value of \[18F\]RCCB6 with that of traditional imaging tracers (e.g., 18F-FDG) and imaging modalities (e.g., CT and MRI). All the above goals will be achieved by analyzing the static/dynamic \[18F\]RCCB6 PET/CT imaging data. Systematic evaluation of these parameters will elucidate the pharmacokinetics, pharmacodynamics, and, more importantly, the clinical value of \[18F\]RCCB6 PET/CT for patients with ccRCC.

Time frame
30 days

Secondary outcomes

1

[18F]RCCB6 PET/CT in changing clinical decision-making for ccRCC patients

After analyzing the imaging parameters and diagnostic/predictive value of \[18F\]RCCB6 PET/CT, we will also investigate how clinical use of \[18F\]RCCB6 PET/CT changes clinical decision-making for ccRCC patients. Joint efforts from nuclear medicine physicians, urologists, oncologists, and pathologists will draw solid conclusions from the imaging and clinical information.

Time frame
3-6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

RenJi Hospital

Lead sponsor

Source ClinicalTrials.gov
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