Renal Cell Carcinoma
Conditions
Keywords
68Ga-NY104, carbonic anhydrase IX
Brief summary
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
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.
Interventions
DIAGNOSTIC_TEST68Ga-NY104 PET/CT
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.
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Written informed consent provided for participation in the trial 2. Age ≥ 18 y 3. at least one of the following indications should be applied 1. Scheduled for surgical resection of renal mass 2. confirmed recurrent/metastatic clear cell renal cell carcinoma 3. suspicion for recurrent/metastatic clear cell renal cell carcinoma
Exclusion criteria
1. On VEGF TKI treatment less than 1 week before 68Ga-NY104 PET/CT. 2. Pregnancy or lactation 3. Severe claustrophobia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Binary reading of focal lesions identified on 68Ga-NY104 PET/CT | From study completion to 1 month after completion | Define lesion as PET positive or PET negative lesion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SUVmax of focal lesions identified on 68Ga-NY104 PET/CT | From study completion to 1 month after completion | 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. |
Countries
China
Contacts
Primary ContactHuo Li, MD
Backup ContactWenjia Zhu, MD
Outcome results
None listed