NCT05749302

Application of Al18F-NOTA-FAPI PET/CT in Malignant Tumors Expressing Fibroblast-activated Proteins

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label whole-body PET/CT study for investigating the value of Al18F-NOTA-FAPI PET/CT in patients with malignant tumors expressing fibroblast-activated proteins

Detailed description

Tumour tissue includes tumour cells as well as stromal cells (vascular cells, inflammatory cells, fibroblasts etc.). Activated fibroblasts are present not only in tumours but also in wound healing and diseases with stromal remodelling, such as chronic inflammation, myocardial infarction and liver and lung fibrosis.There is a correlation between FAP expression and tumour microvascular density and FAP expression is strongly associated with poor prognosis in a variety of tumours (e.g. colon, pancreatic, ovarian and hepatocellular carcinoma).Over 90% of FAP-positive cancer-associated fibroblasts are found in epithelial tumours, whereas fibroblasts in normal tissues rarely or even do not express FAP, making FAP a potential target for imaging and treatment of various malignancies. Al18F-NOTA-FAPI is a posionuclide 18F-labelled tumour developer targeting FAP. Current domestic and international studies have shown that it has good stability and high FAP specificity, and shows excellent imaging quality and tumour detection in tumour-bearing mice and cancer patients, and can be used as a broad-spectrum tumour developer for clinical PET/CT imaging for diagnosis and efficacy assessment of tumour patients.

Conditions

• Malignancy

Interventions

Type	Name	Description
DRUG	Al18F-NOTA-FAPI	Al18F-NOTA-FAPI was injected into the patients before the PET/CT scans

Timeline

• Start date: 2023-01-08
• Primary completion: 2025-03-08
• Completion: 2026-01-08
• First posted: 2023-03-01
• Last updated: 2024-03-29

Locations

1 site across 1 country: China