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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Enrolling; Phase 2

Conditions: Clear Cell Renal Cell Carcinoma

Treatments: Diagnostic Test: 68Ga-NY104 PET/CT

Study type: Interventional

Funder types: Other

Identifiers

NCT05879497

NYCRMS

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

68Ga-NY104 PET/CT

Experimental group

Description:

Each patient will receive one dose of 68Ga-NY104 by intravenous route. Dedicated whole-body PET/CT imaging will be performed.

Treatment:

Diagnostic Test: 68Ga-NY104 PET/CT