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

Malignancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05749302
• Other study ID #: NCC3682
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: January 8, 2023
• Est. completion date: January 8, 2026

Study information

• Verified date: March 2024
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Gouzhu Hou, M.D.
• Phone: 15611145656
• Email: 15611145656[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: January 8, 2026
• Est. primary completion date: March 8, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Malignancy
• Neoplasms

Intervention

Drug:
• Al18F-NOTA-FAPI
Al18F-NOTA-FAPI was injected into the patients before the PET/CT scans

Locations

Country	Name	City	State
China	National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing	Chao Yang

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic value	Sensitivity and Specificity of Al18F-NOTA-FAPI PET/CT for Malignant Tumors Expressing Fibroblast-activated Proteins	through study completion, an average of 1 year