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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Malignancy

Treatments: Drug: Al18F-NOTA-FAPI

Study type: Interventional

Funder types: Other

Identifiers

NCT05749302

NCC3682

Details and patient eligibility

About

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

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with suspected or clearly diagnosed Malignant Tumors Expressing Fibroblast-activated Proteins
• signed written consent.
• Willing and able to cooperate with all projects in this study.

Exclusion criteria

• pregnancy;
• breastfeeding;
• any medical condition that in the opinion of the investigator may significantly interfere with study compliance.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

500 participants in 1 patient group

Al18F-NOTA-FAPI PET/CT

Experimental group

Description:

Al18F-NOTA-FAPI PET/CT will be performed on patients with suspected or clearly diagnosed FAP positive-expressing tumors. The patients were injected with Al18F-NOTA-FAPI and underwent PET/CT scan 20\~40min after the injection.

Treatment:

Drug: Al18F-NOTA-FAPI