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Trial Title:
Application of Al18F-NOTA-FAPI PET/CT in Malignant Tumors Expressing Fibroblast-activated Proteins
NCT ID:
NCT05749302
Condition:
Malignancy
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
malignant tumors expressing fibroblast-activated proteins
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Al18F-NOTA-FAPI
Description:
Al18F-NOTA-FAPI was injected into the patients before the PET/CT scans
Arm group label:
Al18F-NOTA-FAPI PET/CT
Other name:
18F-FAPI
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College
Address:
City:
Beijing
Zip:
100021
Country:
China
Status:
Recruiting
Contact:
Last name:
Guozhu Hou, M.D.
Phone:
15611145656
Email:
15611145656@163.com
Start date:
January 8, 2023
Completion date:
January 8, 2026
Lead sponsor:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Source:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05749302