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Trial Title:
68Ga-NY104 PET/CT in Patients With Metastatic Clear Cell Renal Cell Carcinoma
NCT ID:
NCT05879471
Condition:
Metastatic Clear Cell Renal Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Renal Cell
Conditions: Keywords:
68Ga-NY104
PET/CT
Clear Cell Renal Cell Carcinoma
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, single-arm, comparative phase 2 study in patients
with metastatic clear cell renal cell carcinoma. The goal is to determine the sensitivity
of 68Ga-NY104 PET/CT in patients with metastatic clear cell renal cell carcinoma and
compare it with 18F-FDG PET/CT.
Detailed description:
This is a prospective, single-center, single-arm, comparative phase 2 study in patients
with metastatic clear cell renal cell carcinoma. Each patient will receive one dose of
68Ga-NY104 and one dose of 18F-FDG by intravenous route. Dedicated whole-body PET/CT
imaging will be performed. PET/CT studies will be interpreted by two readers, both of
whom will provide independent, blinded interpretations. Imaging interpretations and a
composite reference standard will be used to estimate the sensitivity of each modality.
The tumor uptake will also be compared for matched lesions.
39 patients will be recruited in Peking Union Medical College Hospital.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age ≥ 18 y
2. Histopathological diagnosis of clear cell renal cell carcinoma
3. Metastatic disease confirmed by histopathology or typical appearance of multifocal
metastatic disease
4. Expected survival of at least 6 months
5. ECOG ≤ 2
6. Written informed consent provided for participation in the trial
7. In the opinion of investigator, willing and able to comply with required study
procedures.
Exclusion Criteria:
1. On VEGF TKI treatment less than 1 week before 68Ga-NY104 PET/CT. TKI is known to
affect girentuximab binding in patients with ccRCC and is expected to have the same
effect on 68Ga-NY104. 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. Patients on HIF antagonist treatment < 3 months before 68Ga-NY104 PET/CT. CA9, which
encodes carbonic anhydrase IX (CAIX), is one of the genes most strongly upregulated
by HIF-1. HIF antagonist, such as Belzutifan, might affect the expression of CAIX
and thus the binding of 68Ga-NY104 to tumor. Withdraw of at least 3 months is
required for HIF antagonist.
3. Pregnancy or breastfeeding.
4. 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, MD
Email:
zhuwenjia_pumc@163.com
Start date:
August 1, 2023
Completion date:
July 1, 2025
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/NCT05879471
