Clinical Trial · NCT05960201

Diagnostic Performance of [18F]FES PET/CT for Axillary LN Metastasis in Invasive Lobular Carcinoma

Overview

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

Sponsor

Asan Medical Center

Phase

Phase 2

Contacts

Sangwon Han (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT05960201

Drug / Compound

fluoroestradiol

Isotope(s):

Target(s):

Estrogen Receptor

Ligand Class: Small Molecules

Eligibility

Inclusion

Subjects whose primary tumor of cT1-3 according to the American Joint Committee on Cancer (AJCC) 8th tumor staging system
Subjects who scheduled to undergo sentinel node biopsy or axillay lymph node dissection within 90 days of \[18F\]FES PET/CT imaging
Subjects with histologically confirmed estrogen receptor-positive invasive lobular breast cancer within 90 days prior to \[18F\]FES PET/CT imaging
Subjects whose Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 2 points or less
Subjects with suspected or confirmed axillary lymph node metastasis clinically or in imaging test (ultrasound)

Exclusion

Subject is a relative or student of the investigator or otherwise in a dependent relationship
Subject not being able to provide intact data for this study due to personal circumstances or other reasons in the judgment of the investigator
Subject has concurrent severe and/or uncontrolled and/or unstable medical condition other than cancer (e.g., congestive heart failure, acute myocardial infarction, severe lung disease, chronic kidney disease or chronic liver disease).
Patients who are scheduled for or have undergone chemotherapy, radiotherapy, antihormone therapy, targeted therapy, or immunotherapy between \[18F\]FES PET/CT and pathological diagnosis
Subjects who are pregnant or lactating. Exclusion of the possibility of pregnancy is made by one of the following: 1) Physiologically menopausal (menstruation has stopped for more than 2 years), 2) Surgically infertility (with a history of bilateral oophorectomy or hysterectomy), 3) In the case of subjects with a possibility of pregnancy, negative serum or urine pregnancy test before administration of \[18F\]FES has to be negative within 24 hours, and the subjects are instructed to use contraception during her participation in this study.
Previous history of ipsilateral axillary lymph node dissection, sentinel lymph node surgery, or lymph node dissection biopsy.
Subjects with confirmed or suspected large, bulky, matted cN2 or cN3 axillary lymph node metastases, or distant metastases.
Subject has already participated in this study