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 range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patient based sensitivity and specificity of qualitative [18F]FES PET/CT evaluation for axillary lymph node metastasis