To hear about similar clinical trials, please enter your email below
Trial Title:
68Ga-NY104 PET/CT Imaging in Renal Cell Carcinoma
NCT ID:
NCT05902377
Condition:
Renal Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Renal Cell
Conditions: Keywords:
68Ga-NY104
carbonic anhydrase IX
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
68Ga-NY104 PET/CT
Description:
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.
Arm group label:
68Ga-NY104 PET/CT
Other name:
68Ga-NYM005 PET/CT
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100730
Country:
China
Status:
Recruiting
Contact:
Last name:
Wenjia Zhu
Phone:
18614080164
Email:
zhuwenjia_pumc@163.com
Start date:
December 1, 2021
Completion date:
July 1, 2023
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05902377
