Diagnostic Performance of [18F]FES PET/CT for Axillary LN Metastasis in Invasive Lobular Carcinoma
- Conditions
- Carcinoma, Lobular
- Registration Number
- NCT05960201
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Male or female subjects aged 19 years or older regardless of race/ethnicity.<br><br> - Subjects with histologically confirmed estrogen receptor-positive invasive lobular<br> breast cancer within 90 days prior to [18F]FES PET/CT imaging<br><br> - Subjects whose primary tumor of cT1-3 according to the American Joint Committee on<br> Cancer (AJCC) 8th tumor staging system<br><br> - Subjects with suspected or confirmed axillary lymph node metastasis clinically or in<br> imaging test (ultrasound)<br><br> - Subjects who scheduled to undergo sentinel node biopsy or axillay lymph node<br> dissection within 90 days of [18F]FES PET/CT imaging<br><br> - Subjects whose Eastern Cooperative Oncology Group (ECOG) performance status (PS) of<br> 2 points or less<br><br>Exclusion Criteria:<br><br> - Subject or the subject's legally acceptable representative does not provide written<br> informed consent form<br><br> - Subjects with confirmed or suspected large, bulky, matted cN2 or cN3 axillary lymph<br> node metastases, or distant metastases.<br><br> - Previous history of ipsilateral axillary lymph node dissection, sentinel lymph node<br> surgery, or lymph node dissection biopsy.<br><br> - Patients who are scheduled for or have undergone chemotherapy, radiotherapy,<br> antihormone therapy, targeted therapy, or immunotherapy between [18F]FES PET/CT and<br> pathological diagnosis<br><br> - Subjects who are pregnant or lactating. Exclusion of the possibility of pregnancy is<br> made by one of the following: 1) Physiologically menopausal (menstruation has<br> stopped for more than 2 years), 2) Surgically infertility (with a history of<br> bilateral oophorectomy or hysterectomy), 3) In the case of subjects with a<br> possibility of pregnancy, negative serum or urine pregnancy test before<br> administration of [18F]FES has to be negative within 24 hours, and the subjects are<br> instructed to use contraception during her participation in this study.<br><br> - Subject has concurrent severe and/or uncontrolled and/or unstable medical condition<br> other than cancer (e.g., congestive heart failure, acute myocardial infarction,<br> severe lung disease, chronic kidney disease or chronic liver disease).<br><br> - Subject is a relative or student of the investigator or otherwise in a dependent<br> relationship<br><br> - Subject has already participated in this study<br><br> - Subject not being able to provide intact data for this study due to personal<br> circumstances or other reasons in the judgment of the investigator
Not provided
Study & Design
- Study Type
- Interventional
- 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