Diagnostic Performance of [18F]FES PET/CT for Axillary LN Metastasis in Invasive Lobular Carcinoma
Carcinoma, Lobular
About this trial
This is an interventional diagnostic trial for Carcinoma, Lobular
Eligibility Criteria
Inclusion Criteria: Male or female subjects aged 19 years or older regardless of race/ethnicity. Subjects with histologically confirmed estrogen receptor-positive invasive lobular breast cancer within 90 days prior to [18F]FES PET/CT imaging Subjects whose primary tumor of cT1-3 according to the American Joint Committee on Cancer (AJCC) 8th tumor staging system Subjects with suspected or confirmed axillary lymph node metastasis clinically or in imaging test (ultrasound) Subjects who scheduled to undergo sentinel node biopsy or axillay lymph node dissection within 90 days of [18F]FES PET/CT imaging Subjects whose Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 2 points or less Exclusion Criteria: Subject or the subject's legally acceptable representative does not provide written informed consent form Subjects with confirmed or suspected large, bulky, matted cN2 or cN3 axillary lymph node metastases, or distant metastases. Previous history of ipsilateral axillary lymph node dissection, sentinel lymph node surgery, or lymph node dissection biopsy. 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. 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). Subject is a relative or student of the investigator or otherwise in a dependent relationship Subject has already participated in this study Subject not being able to provide intact data for this study due to personal circumstances or other reasons in the judgment of the investigator
Sites / Locations
- Asan Medical CenterRecruiting
Arms of the Study
Arm 1
Experimental
invasive lobular breast cancer
images for 90 minutes after F-18 FES injection