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

NCT05728515 | Completed Early Phase 1

• 1 other identifier: NYPILOT
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Clear Cell Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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

• Tumor uptake of 68Ga-NY104

  Uptake measured by SUVmax and SUVmean in suspected tumor lesions

  From study completion to 2 hour after completion

Study Arms (1)

PET scan

EXPERIMENTAL

Patients will receive an intravenous injection of 68Ga-NY104

Drug: 68Ga-NY104

Interventions

68Ga-NY104 DRUG

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

Also known as: no other intervention name

PET scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• Pregnancy or breastfeeding.
• Severe claustrophobia.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (1)

• Zhu W, Li X, Zheng G, Bai C, Ji Z, Zhang H, Xing H, Zhang Y, Huo L. Preclinical and pilot clinical evaluation of a small-molecule carbonic anhydrase IX targeting PET tracer in clear cell renal cell carcinoma. Eur J Nucl Med Mol Imaging. 2023 Aug;50(10):3116-3125. doi: 10.1007/s00259-023-06248-7. Epub 2023 May 29.

  PMID: 37246998 DERIVED

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Li Huo

  Peking Uion Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: February 15, 2023
• Study Start: December 25, 2021
• Primary Completion: March 4, 2022
• Study Completion: March 4, 2022
• Last Updated: February 15, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)