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

Clear Cell Renal Cell Carcinoma Clinical Trial

Official title:

Pilot Clinical Evaluation of a Small-molecule Carbonic Anhydrase IX Targeting PET Tracer in Clear Cell Renal Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05728515
• Other study ID #: NYPILOT
• Status: Completed
• Phase: Early Phase 1
• Start date: December 25, 2021
• Est. completion date: March 4, 2022

Study information

• Verified date: February 2023
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: March 4, 2022
• Est. primary completion date: March 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Clear Cell Renal Cell Carcinoma

Intervention

Drug:
• 68Ga-NY104
Patients will undergo PET/CT scans after receiving an intravenous injection of 68Ga-NY104

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