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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Completed; Early Phase 1

Conditions: Clear Cell Renal Cell Carcinoma

Treatments: Drug: 68Ga-NY104

Study type: Interventional

Funder types: Other

Identifiers

NCT05728515

NYPILOT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

PET scan

Experimental group

Description:

Patients will receive an intravenous injection of 68Ga-NY104

Treatment:

Drug: 68Ga-NY104