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

Phase 2

Recruiting

• Conditions: Renal Cell Carcinoma
• Interventions: Diagnostic Test: 68Ga-NY104 PET/CT

• Registration Number: NCT05902377
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2021-12-01
• Status Verified: 2023-06
• Study First Submitted: 2023-06-05
• Study First Submitted QC: 2023-06-05
• Last Update Submitted: 2023-06-05
• Study First Posted: 2023-06-15
• Last Update Posted: 2023-06-15
• Primary Completion: 2023-07-01
• Study Completion: 2023-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 46

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Binary reading of focal lesions identified on 68Ga-NY104 PET/CT	From study completion to 1 month after completion	Define lesion as PET positive or PET negative lesion.

Secondary Outcome Measures

Name	Time	Method
SUVmax of focal lesions identified on 68Ga-NY104 PET/CT	From study completion to 1 month after completion	the tracer uptake is quantified using maximal standard uptake value (SUVmax) by drawing a 3-dimensional region of interest (ROI) over the lesion using a threshold of 40% SUVmax.

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China