68Ga-NY104 PET/CT Imaging in Renal Cell Carcinoma

Study Overview
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Brief Summary
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This is a prospective, single-center study in patients with renal cell carcinoma. The goal is to determine the sensitivity and specificity of 68Ga-NY104 PET/CT in the detection of clear cell renal cell carcinoma.

Detailed Description
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Two types of patients will be recruited in this study. Type 1, patients with renal masses scheduled for surgery, type 2, patients with confirmed or suspicious recurrent/metastatic ccRCC. Each patient will receive one dose of 68Ga-NY104 by intravenous route. Dedicated whole-body PET/CT imaging will be performed. Imaging interpretations and reference standards will be used to estimate the sensitivity and specificity of 68G-NY104 PET/CT. 46 patients will be recruited in Peking Union Medical College Hospital. This study will be conducted according to local regulations and laws, the ethical principles that have their origin in the Declaration of Helsinki, and the principles of Good Clinical Practice.

Official Title
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68Ga-NY104 PET/CT Imaging in Patients With Confirmed or Suspicious Renal Cell Carcinoma

Conditions
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Renal Cell Carcinoma

Intervention / Treatment
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* Diagnostic Test: 68Ga-NY104 PET/CT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent provided for participation in the trial Age ≥ 18 y at least one of the following indications should be applied Scheduled for surgical resection of renal mass confirmed recurrent/metastatic clear cell renal cell carcinoma suspicion for recurrent/metastatic clear cell renal cell carcinoma Exclusion Criteria: On VEGF TKI treatment less than 1 week before 68Ga-NY104 PET/CT. Pregnancy or lactation Severe claustrophobia.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 68Ga-NY104 PET/CT<br>Each patient will receive one dose of 68Ga-NY104 by intravenous route. Dedicated whole-body PET/CT imaging will be performed. | Diagnostic Test: 68Ga-NY104 PET/CT<br>* Participants will be administered a single, intravenous bolus of 68Ga-NY104 The recommended administered activity of 68Ga-NY104 is 1.8-2.2 MBq per kilogram bodyweight, subject to variation that may be required owing to variable elution efficiencies obtained during the lifetime of the 68Ga / 68Ga generator. The CT and PET imaging session will begin approximately 45 to 75 minutes after 68Ga-NY104 administration.<br>* Other names: 68Ga-NYM005 PET/CT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binary reading of focal lesions identified on 68Ga-NY104 PET/CT | Define lesion as PET positive or PET negative lesion. | From study completion to 1 month after completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SUVmax of focal lesions identified on 68Ga-NY104 PET/CT | the tracer uptake is quantified using maximal standard uptake value (SUVmax) by drawing a 3-dimensional region of interest (ROI) over the lesion using a threshold of 40% SUVmax. | From study completion to 1 month after completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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68Ga-NY104, carbonic anhydrase IX