68Ga-NY104 PET/CT in Patients With Metastasis/Recurrence Clear Cell Renal Cell Carcinoma Suspicion

Clear Cell Renal Cell Carcinoma Clinical Trial

Official title:

68Ga-NY104 PET/CT in Patients With Metastasis/Recurrence Clear Cell Renal Cell Carcinoma Suspicion: a Prospective, Single Center, Single Arm Imaging Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05879497
• Other study ID #: NYCRMS
• 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 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• 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. 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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Clear Cell Renal Cell Carcinoma
• Recurrence

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	Binary reading of lesions identified on 68Ga-NY104 PET/CT	Any focal accumulation in the lesion suspected of metastasis or recurrence that cannot be explained by physiologic uptake of 68Ga-NY104 will be interpreted as PET positive.	From study completion to 1 month after completion