Clinical trial NCT05879471: 68Ga-NY104 PET/CT in Patients With Metastatic Clear Cell Renal Cell Carcinoma
Official title: 68Ga-NY104 PET/CT and 18F-FDG PET/CT in Patients With Metastatic Clear Cell Renal Cell Carcinoma: a Prospective, Single Center, Single Arm, Comparative Imaging Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Metastatic Clear Cell Renal Cell Carcinoma
Keywords: 68Ga-NY104
PET/CT
Clear Cell Renal Cell Carcinoma
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-05-30
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Primary outcomes:
measure: Positivity of lesions detected by 68Ga-NY104 PET
timeFrame: From study completion to 1 month after completion
measure: Positivity of lesions detected by 18F-FDG PET
timeFrame: From study completion to 1 month after completion
Secondary outcomes:
measure: SUVmax of lesions detected by 68Ga-NY104 PET
timeFrame: From study completion to 1 month after completion
measure: SUVmax of lesions detected by 18F-FDG PET
timeFrame: From study completion to 1 month after completion
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Uion Medical College Hospital
name: Li Huo, MD
role: PRINCIPAL_INVESTIGATOR
References: