Study Title

A Phase 2, Open-label, Non-randomized, Single Center Study to Explore Diagnostic Performance of [18F]fluoroestradiol (FES) Positron Emission Tomography/computed Tomography for the Assessment of Axillary Lymph Node Metastasis in Estrogen-positive Breast Cancer

Study Details

Description:

This study aims to explore the diagnostic performance of [18F]FES PET/CT for the evaluation of axillary lymph node metastasis in patients with ER-positive breast cancer having clinically suspected or confirmed axillary lymph node metastasis.

Sponsor:

Asan Medical Center

Contacts:

Sangwon Han

hswon87@amc.seoul.kr

+82-2-3010-0657

Jaeeun Kim

kje0216@amc.seoul.kr

+82-2-3010-4572

Government Study Link:

NCT06695039 - Click here to see study on

ClinicalTrials.gov

Drug Details

[18F]FES
Isotope(s):
    FLUORINE-18
    Radioisotope: F-18
    Theranostic Role: PET Imaging
    T1/2 (Half-Life): 1.8 Hours
    Decay Mode: POSITRON β+ (96.7%), ELECTRON CAPTURE (3.3%), GAMMA 511 keV
    Energy: Eβ+ 635 keV
    Range: N/A
    Decay Daughters: O18 (Stable)
    Status: FDA Approvals: FDG (Cancer 2005): GLUDEF®, METATRACE® AXUMIN® (2016), PYLARIFY® (2023), POSLUMA® (2024)
  • FLUORINE-18
Target(s):
  • 17β-estradiol

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