68Ga-NY104 PET/CT in Patients With Metastatic Clear Cell Renal Cell Carcinoma

Metastatic Clear Cell Renal Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05879471
• Other study ID #: NYCRM
• Status: Recruiting
• Phase: Phase 2
• Start date: August 1, 2023
• Est. completion date: July 1, 2025

Study information

• Verified date: July 2023
• Source: Peking Union Medical College Hospital
• Contact: Li Huo, MD
• Phone: 18612672038
• Email: huoli[@]pumch.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 39
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Metastatic Clear Cell Renal Cell Carcinoma

Intervention

Diagnostic Test:
• 68Ga-NY104 PET/CT
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.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positivity of lesions detected by 68Ga-NY104 PET	Any focal accumulation that cannot be explained by physiologic uptake of the 68Ga-NY104 will be interpreted as focal lesion.	From study completion to 1 month after completion
Primary	Positivity of lesions detected by 18F-FDG PET	Any focal accumulation that cannot be explained by physiologic uptake of 18F-FDG will be interpreted as focal lesion.	From study completion to 1 month after completion
Secondary	SUVmax of lesions detected by 68Ga-NY104 PET	The tracer uptake in focal lesions is quantified using maximal standard uptake value (SUVmax) by drawing a 3-dimentional region of interest (ROI) over the lesion using a threshold of 40% SUVmax.	From study completion to 1 month after completion
Secondary	SUVmax of lesions detected by 18F-FDG PET	The tracer uptake in focal lesions is quantified using maximal standard uptake value (SUVmax) by drawing a 3-dimentional region of interest (ROI) over the lesion using a threshold of 40% SUVmax.	From study completion to 1 month after completion