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

NCT ID: NCT05749302

Last Updated: 2024-03-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-08
• Study Completion Date: 2026-01-08

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Al18F-NOTA-FAPI PET/CT

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.

Group Type: EXPERIMENTAL

Al18F-NOTA-FAPI

Intervention Type: DRUG

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

Interventions

Al18F-NOTA-FAPI

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

Intervention Type: DRUG

Other Intervention Names

18F-FAPI

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rong Zheng, M.D.

Role: STUDY_DIRECTOR

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and PUMC

Locations

National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Chao Yang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Gouzhu Hou, M.D.

Role: CONTACT

15611145656@163.com

15611145656

Xin Cheng, M.D.

Role: CONTACT

cxpumc@foxmail.com

15120002998

Facility Contacts

Guozhu Hou, M.D.

Role: primary

15611145656@163.com

15611145656

Other Identifiers

NCC3682

Identifier Type: -

Identifier Source: org_study_id