Clear Cell Renal Cell Carcinoma
Conditions
Brief summary
The goal of this pilot clinical trial is to see the potential application of a CAIX targeted PET. tracer in patients with clear cell renal cell carcinoma. The main question\[s\] it aims to answer are: * The biodistribution of the PET tracer * Whether RCC lesions can be identified by the PET tracer Participants will undergo 68Ga-NY104 PET/CT scan and images will be reviewed by nuclear medicine specialists.
Detailed description
PET/CT imaging of three patients using 68Ga-NY104 for medical reasons will be performed. Patients received an intravenous injection of 68Ga-NY104. Images will be obtained at 0.5 h, 1 h, and 2 h after injection. A comparative 18F-FDG PET/CT scan will also be performed if necessary. The study will be carried out on a time-of-flight PET/CT scanner. SUVmax and SUVmean of normal organs and lesions, as well as tumor-to-background ratios, will be quantitatively assessed using a region-of-interest technique.
Interventions
DRUG68Ga-NY104
Patients will undergo PET/CT scans after receiving an intravenous injection of 68Ga-NY104
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. Confirmed or suspected metastatic ccRCC 2. Age ≥ 18 y 3. Written informed consent provided for participation in the trial 4. In the opinion of investigator, willing and able to comply with required study procedures.
Exclusion criteria
1. Patients on VEGF TKI treatment \< 1 week before 68Ga-NY104 PET/CT. TKI is known to affect girentuximab binding in patients with ccRCC. If patients were on VEGF TKI treatment, such as sunitinib, sorafenib, cabozantinib, pazopanib, or lenvatinib, a washout of one week before 68Ga-NY104 PET/CT is required. 2. Pregnancy or breastfeeding. 3. Severe claustrophobia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biodistribution of 68Ga-NY104 in normal organs | From study completion to 2 hour after completion | Uptake measured by SUVmax and SUVmean in normal organs using a region-of-interest technique |
| Tumor uptake of 68Ga-NY104 | From study completion to 2 hour after completion | Uptake measured by SUVmax and SUVmean in suspected tumor lesions |
Countries
China
Outcome results
None listed