Evaluating a new imaging method for breast cancer lymph node metastasis
A Phase 2, Open-label, Non-randomized, Single Center Study to Explore Diagnostic Performance of [18F]fluoroestradiol (FES) Positron Emission Tomography/computed Tomography for the Assessment of Axillary Lymph Node Metastasis in Estrogen-positive Breast Cancer
PHASE2 · Asan Medical Center · NCT06695039
This study is testing a new imaging method to see if it can better detect lymph node spread in patients with estrogen receptor-positive breast cancer who are about to have surgery.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 77 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Asan Medical Center (other) |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06695039 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of [18F]FES PET/CT imaging in diagnosing axillary lymph node metastasis in patients with estrogen receptor-positive breast cancer. It focuses on individuals who have clinically suspected or confirmed lymph node involvement and are scheduled for surgical procedures like sentinel node biopsy. The study aims to enhance preoperative evaluations, potentially reducing unnecessary surgeries and improving patient outcomes. By assessing the diagnostic performance of this imaging technique, the research seeks to provide valuable insights into the management of breast cancer.
Who should consider this trial
Good fit: Ideal candidates include adults aged 19 and older with confirmed estrogen receptor-positive invasive breast cancer and suspected axillary lymph node metastasis.
Not a fit: Patients with confirmed or suspected distant metastases or those who have previously undergone axillary lymph node dissection may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate preoperative assessments, allowing for tailored surgical approaches and potentially reducing complications for patients.
How similar studies have performed: Other studies have shown promise in using advanced imaging techniques for cancer staging, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 oophorectomy or hysterectomy), 3) In the case of subjects with a possibility of pregnancy, negative serum or urine pregnancy test before administration of \[18F\]FES has to be negative within 24 hours, and the subjects are instructed to use contraception during her participation in this study. * Subject has concurrent severe and/or uncontrolled and/or unstable medical condition other than cancer (e.g., congestive heart failure, acute myocardial infarction, severe lung disease, chronic kidney disease or chronic liver disease). * Subject is a relative or student of the investigator or otherwise in a dependent relationship * Subject has already participated in this study * Subject not being able to provide intact data for this study due to personal circumstances or other reasons in the judgment of the investigator
Where this trial is running
Seoul
- Asan Medical Center — Seoul, Korea, Republic of (RECRUITING)
Study contacts
- Principal investigator: Sangwon Han, Clinical assistant professor — Asan Medical Center
- Study coordinator: Sangwon Han
- Email: hswon87@amc.seoul.kr
- Phone: +82-2-3010-0657
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer Invasive, breast caner, estrogen receptor, [18F]FES PET/CT, axillary lymph node