None listed
Conditions
Interventions
Drug : 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 olderregardless of race/ethnicity. - Subjects with histologically confirmed estrogenreceptor-positive invasive lobular breast cancerwithin 90 days prior to [18F]FES PET/CTimaging - Subjects whose primary tumor of cT1-3according to the American Joint Committee onCancer (AJCC) 8th tumor staging system - Subjects with suspected or confirmed axillarylymph node metastasis clinically or in imagingtest (ultrasound) - Subjects who scheduled to undergo sentinelnode biopsy or axillay lymph node dissectionwithin 90 days of [18F]FES PET/CT imaging - Subjects whose Eastern Cooperative OncologyGroup (ECOG) performance status (PS) of 2points or less
Exclusion criteria
Exclusion criteria: - Subject or the subject's legally acceptablerepresentative does not provide writteninformed consent form - Subjects with confirmed or suspected large,bulky, matted cN2 or cN3 axillary lymph nodemetastases, or distant metastases. - Previous history of ipsilateral axillary lymphnode dissection, sentinel lymph node surgery,or lymph node dissection biopsy. - Patients who are scheduled for or haveundergone chemotherapy, radiotherapy,antihormone therapy, targeted therapy, orimmunotherapy between [18F]FES PET/CT andpathological diagnosis - Subjects who are pregnant or lactating.Exclusion of the possibility of pregnancy ismade by one of the following: 1)Physiologically menopausal (menstruation hasstopped for more than 2 years), 2) Surgicallyinfertility (with a history of bilateral oophorectomy or hysterectomy), 3) In the caseof subjects with a possibility of pregnancy,negative serum or urine pregnancy test beforeadministration of [18F]FES has to be negativewithin 24 hours, and the subjects are instructedto use contraception during her participation inthis study. - Subject has concurrent severe and/oruncontrolled and/or unstable medical conditionother than cancer (e.g., congestive heart failure,acute myocardial infarction, severe lungdisease, chronic kidney disease or chronic liverdisease). - Subject is a relative or student of theinvestigator or otherwise in a dependentrelationship - Subject has already participated in this study - Subject not being able to provide intact datafor this study due to personal circumstances orother reasons in the judgment of theinvestigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Patient based sensitivity, specificity, positive predictive and negative predictive values of a qualitative [18F]FES PET/CT assessment of axillary lymph node metastasis | — |
Secondary
| Measure | Time frame |
|---|---|
| • Patient based sensitivity, specificity, positive predictive and negative predictive values of quantitative [ 18 F]FES PET/CT evaluation for axillary lymph node metastasis • Patient based sensitivity, specificity, positive predictive and negative predictive values of [18F]FES PET/CT in FNA or CNB-negative patients • Detection rate of qualitative [18F]FES PET/CT evaluation for cN3 lymph node metastasis • Detection rate of qualitative [18F]FES PET/CT evaluation for distant metastasis | — |
Countries
Korea, Republic of
Contacts
Public ContactJae Eun Kim
Asan Medical Center
Outcome results
None listed