study to explore diagnostic performance of [18F]fluoroestradiol (FES) positron emission tomography/computed tomography for the assessment of axillary lymph node metastasis in invasive lobular carcinoma of the breast
- Conditions
- Neoplasms
- Registration Number
- KCT0008590
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
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
- 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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method • Patient based sensitivity, specificity, positive predictive and negative predictive values of a qualitative [18F]FES PET/CT assessment of axillary lymph node metastasis
- Secondary Outcome Measures
Name Time Method • 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