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

Renal Cell Carcinoma Clinical Trial

Official title:

68Ga-NY104 PET/CT Imaging in Patients With Confirmed or Suspicious Renal Cell Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05902377
• Other study ID #: NYCR
• Status: Recruiting
• Phase: Phase 2
• Start date: December 1, 2021
• Est. completion date: July 1, 2023

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal 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	Binary reading of focal lesions identified on 68Ga-NY104 PET/CT	Define lesion as PET positive or PET negative lesion.	From study completion to 1 month after completion
Secondary	SUVmax of focal lesions identified on 68Ga-NY104 PET/CT	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.	From study completion to 1 month after completion