None listed
Conditions
Interventions
Others : Fluoroestradiol (18F)
PET/CT images for 90 minutes after F-18 FES injection
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female subjects aged 19 years or older regardless of race/ethnicity. • Subjects with histologically confirmed moderate-to-strong estrogen receptor-positive invasive 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 axillary 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
Exclusion criteria: Subject or the subjects legally acceptable representative does not provide written informed consent form • Subjects with confirmed or suspected 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient based sensitivity and specificity of qualitative [18F]FES PET/CT evaluation for axillary lymph node metastasis | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient based sensitivity and specificity of qualitative [18F]FES PET/CT evaluation for pN2/3 axillary lymph node metastasis;Patient based sensitivity, specificity, area under ROC curve of quantitative [18F]FES PET/CT evaluation for axillary lymph node metastasis;Detection rate of qualitative [18F]FES PET/CT evaluation for internal mammary or supraclavicular lymph node metastasis;Detection rate of qualitative [18F]FES PET/CT evaluation for distant metastasis | — |
Countries
Korea, Republic of
Contacts
Public ContactHan Sangwon
Asan Medical Center
Outcome results
None listed