NCT05637034

68Ga-DOTA-F2 PET/CT in Patients With Various Types of Cancer

Clinical Applications of Fibroblast Activation Protein Inhibitor-Based Dimeric Radiotracer 68Ga-DOTA-F2 PET/CT Imaging for Malignant Tumors

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the potential usefulness of 68Ga-DOTA-F2 positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various types of cancer, compared with 18F-FDG PET/CT.

Detailed description

Quinoline-based fibroblast activation protein (FAP) inhibitors (FAPIs; e.g., FAPI-04 and FAPI-46), which have shown promising results in the diagnosis of cancer and various other diseases in recent years, have become the focus of much productive research. Despite this, one major issue is that these FAPI molecules have a relatively short tumor retention time, which may limit their use in targeted radionuclide therapy applications. As a result, 68Ga-DOTA-F2, a novel dimeric FAPI molecule, was developed to increase tracer uptake and retention in tumors for potential therapeutic or theranostic applications. In preclinical study, 68Ga-DOTA-F2 has shown better tumor uptake and longer tumor retention time than 68Ga-FAPI in mouse tumor models. Our study will assess image quality and evaluate the diagnostic performance of 68Ga-DOTA-F2. Patients with histologically confirmed malignant tumors will be prospectively recruited in this study.

Conditions

• Tumor, Solid

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	68Ga-DOTA-F2 PET/CT and 18F-FDG	Each subject receive a single intravenous injection of 68Ga-DOTA-F2 and 18F-FDG, and undergo PET/CT imaging within the specified time.

Timeline

• Start date: 2022-09-15
• Primary completion: 2023-09-15
• Completion: 2023-09-15
• First posted: 2022-12-05
• Last updated: 2022-12-05

Locations

1 site across 1 country: China