68Ga-NY104 PET/CT Imaging in Renal Cell Carcinoma

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Enrolling; Phase 2

Conditions: Renal Cell Carcinoma

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05902377

NYCR

Details and patient eligibility

About

This is a prospective, single-center study in patients with renal cell carcinoma. The goal is to determine the sensitivity and specificity of 68Ga-NY104 PET/CT in the detection of clear cell renal cell carcinoma.

Full description

Two types of patients will be recruited in this study. Type 1, patients with renal masses scheduled for surgery, type 2, patients with confirmed or suspicious recurrent/metastatic ccRCC. Each patient will receive one dose of 68Ga-NY104 by intravenous route. Dedicated whole-body PET/CT imaging will be performed. Imaging interpretations and reference standards will be used to estimate the sensitivity and specificity of 68G-NY104 PET/CT.

46 patients will be recruited in Peking Union Medical College Hospital. This study will be conducted according to local regulations and laws, the ethical principles that have their origin in the Declaration of Helsinki, and the principles of Good Clinical Practice.

Enrollment: 46 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Written informed consent provided for participation in the trial

2. Age ≥ 18 y

3. at least one of the following indications should be applied

   1. Scheduled for surgical resection of renal mass
   2. confirmed recurrent/metastatic clear cell renal cell carcinoma
   3. suspicion for recurrent/metastatic clear cell renal cell carcinoma

Exclusion criteria

1. On VEGF TKI treatment less than 1 week before 68Ga-NY104 PET/CT.
2. Pregnancy or lactation
3. Severe claustrophobia.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 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