Diagnostic Performance of [18F]FES PET/CT for Axillary LN Metastasis in ER-positive Breast Cancer (NCT06695039) | Clinical Trial Compass
CompletedPhase 2
Diagnostic Performance of [18F]FES PET/CT for Axillary LN Metastasis in ER-positive Breast Cancer
South Korea71 participantsStarted 2024-11-18
Plain-language summary
This study aims to explore the diagnostic performance of \[18F\]FES PET/CT for the evaluation of axillary lymph node metastasis in patients with ER-positive breast cancer having clinically suspected or confirmed axillary lymph node metastasis.
Who can participate
Age range19 Years
SexALL
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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:
* Subject or the subject's 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 oophorec…
What they're measuring
1
Patient based sensitivity and specificity of qualitative [18F]FES PET/CT evaluation for axillary lymph node metastasis