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Trial Title:
68Ga-NY104 PET/CT in Patients With Metastasis/Recurrence Clear Cell Renal Cell Carcinoma Suspicion
NCT ID:
NCT05879497
Condition:
Clear Cell Renal Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Renal Cell
Recurrence
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 phase 2 study in patients with clear
cell renal cell carcinoma and metastasis or recurrence suspicion. The goal is to
determine the sensitivity and specificity of 68Ga-NY104 PET/CT in patients with clear
cell renal cell carcinoma and metastasis or recurrence suspicion
Detailed description:
This is a prospective, single-center, single-arm phase 2 study in patients with clear
cell renal cell carcinoma and metastasis or recurrence suspicion. Each patient will
receive one dose of 68Ga-NY104. Dedicated whole-body PET/CT imaging will be performed.
PET/CT studies will be interpreted by two readers, both of whom will provide independent
and blinded interpretations. Imaging interpretations and a composite ground truth will be
used to estimate the diagnostic efficacy of 68Ga-NY104 PET/CT.
A total of 40 patients will be recruited at 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. Suspected of metastasis or recurrence from ccRCC based on previous conventional
imaging or 18F-FDG PET/CT scan.
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/NCT05879497
