A Small-molecule Carbonic Anhydrase IX Targeting PET Tracer in Clear Cell Renal Cell Carcinoma

Early Phase 1

Completed

• Conditions: Clear Cell Renal Cell Carcinoma
• Interventions: Drug: 68Ga-NY104

• Registration Number: NCT05728515
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

The goal of this pilot clinical trial is to see the potential application of a CAIX targeted PET. tracer in patients with clear cell renal cell carcinoma. The main question\[s\] it aims to answer are:

* The biodistribution of the PET tracer

* Whether RCC lesions can be identified by the PET tracer Participants will undergo 68Ga-NY104 PET/CT scan and images will be reviewed by nuclear medicine specialists.

Detailed Description

PET/CT imaging of three patients using 68Ga-NY104 for medical reasons will be performed. Patients received an intravenous injection of 68Ga-NY104. Images will be obtained at 0.5 h, 1 h, and 2 h after injection. A comparative 18F-FDG PET/CT scan will also be performed if necessary. The study will be carried out on a time-of-flight PET/CT scanner. SUVmax and SUVmean of normal organs and lesions, as well as tumor-to-background ratios, will be quantitatively assessed using a region-of-interest technique.

Study Timeline

• Study Start: 2021-12-25
• Primary Completion: 2022-03-04
• Study Completion: 2022-03-04
• Status Verified: 2023-02
• Study First Submitted: 2023-02-06
• Study First Submitted QC: 2023-02-06
• Last Update Submitted: 2023-02-06
• Study First Posted: 2023-02-15
• Last Update Posted: 2023-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

1. Confirmed or suspected metastatic ccRCC
2. Age ≥ 18 y
3. Written informed consent provided for participation in the trial
4. In the opinion of investigator, willing and able to comply with required study procedures.

Exclusion Criteria

1. Patients on VEGF TKI treatment < 1 week before 68Ga-NY104 PET/CT. TKI is known to affect girentuximab binding in patients with ccRCC. 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. Pregnancy or breastfeeding.
3. Severe claustrophobia.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PET scan	68Ga-NY104	Patients will receive an intravenous injection of 68Ga-NY104

Primary Outcome Measures

Name	Time	Method
Tumor uptake of 68Ga-NY104	From study completion to 2 hour after completion	Uptake measured by SUVmax and SUVmean in suspected tumor lesions
Biodistribution of 68Ga-NY104 in normal organs	From study completion to 2 hour after completion	Uptake measured by SUVmax and SUVmean in normal organs using a region-of-interest technique

Trial Locations

Locations (1)

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