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

Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT05749302
Collaborator
(none)
50
Enrollment
1
Location
1
Arm
24
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 1

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Application of Al18F-NOTA-FAPI PET/CT in Malignant Tumors Expressing Fibroblast-activated Proteins
Actual Study Start Date :
Jan 8, 2023
Anticipated Primary Completion Date :
Jan 8, 2024
Anticipated Study Completion Date :
Jan 8, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: Al18F-NOTA-FAPI
Al18F-NOTA-FAPI was injected into the patients before the PET/CT scans
Other Names:
  • 18F-FAPI

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Diagnostic value [through study completion, an average of 1 year]

      Sensitivity and Specificity of Al18F-NOTA-FAPI PET/CT for Malignant Tumors Expressing Fibroblast-activated Proteins

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College Beijing Chao Yang China 100021

    Sponsors and Collaborators

    • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    Investigators

    • Study Director: Rong Zheng, M.D., National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and PUMC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cancer Institute and Hospital, Chinese Academy of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT05749302
    Other Study ID Numbers:
    • NCC3682
    First Posted:
    Mar 1, 2023
    Last Update Posted:
    Mar 1, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Cancer Institute and Hospital, Chinese Academy of Medical Sciences
    malignant tumors expressing fibroblast-activated proteins
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    No Results Posted as of Mar 1, 2023