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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

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