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New treatment option for Stage III Breast Cancer
Official title [18F]FES PET/CT for the Detection of Distant Metastasis in Low-grade ER-positive Stage III Breast Cancer
ClinicalTrials.gov ID: NCT07314073
What this study is testing
- What it's testing
- This study aims to evaluate the detection rate of distant metastases using [18F]FES PET/CT in patients with low-grade, ER-positive stage III breast cancer.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- Male or female patients aged ≥19 years, regardless of race/ethnicity
- Patients newly diagnosed with invasive breast cancer within 90 days prior to screening, with documented histopathological confirmation.
- Patients diagnosed with histologically confirmed estrogen receptor-positive, histologic grade 1 or 2 primary breast cancer
- Patients with clinical stage IIIA-IIIC disease according to the 8th edition of the American Joint Committee on Cancer (AJCC) TNM staging system
- Patients who have undergone, or are scheduled to undergo chest computed tomography (CT), abdominal CT, and bone scintigraphy within 90 days prior to...
You likely can't join if
- The subject or the subject's legally authorized representative has not signed the informed consent form
- people who are currently receiving systemic therapy for breast cancer (e.g., neoadjuvant chemotherapy, hormonal therapy)
- people with a history of another invasive malignancy within the past 2 years (except for non-melanoma skin cancer)
- people diagnosed with distant metastases on chest CT, abdominal CT, or bone scintigraphy performed within 90 days prior to screening or before the...
- people for whom neither biopsy nor ≥6 months of follow-up imaging has been performed for lesions suspicious for distant metastases
- Pregnant or breastfeeding women. The following cases are considered not at risk of pregnancy: (1) physiologically postmenopausal (no menses for ≥2...
See the full eligibility criteria
- Male or female patients aged ≥19 years, regardless of race/ethnicity
- Patients newly diagnosed with invasive breast cancer within 90 days prior to screening, with documented histopathological confirmation.
- Patients diagnosed with histologically confirmed estrogen receptor-positive, histologic grade 1 or 2 primary breast cancer
- Patients with clinical stage IIIA-IIIC disease according to the 8th edition of the American Joint Committee on Cancer (AJCC) TNM staging system
- Patients who have undergone, or are scheduled to undergo chest computed tomography (CT), abdominal CT, and bone scintigraphy within 90 days prior to screening before the 18F-FES PET/CT scan
- Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of ≤2
- The subject or the subject's legally authorized representative has not signed the informed consent form
- people who are currently receiving systemic therapy for breast cancer (e.g., neoadjuvant chemotherapy, hormonal therapy)
- people with a history of another invasive malignancy within the past 2 years (except for non-melanoma skin cancer)
- people diagnosed with distant metastases on chest CT, abdominal CT, or bone scintigraphy performed within 90 days prior to screening or before the 18F-FES PET/CT scan
- people for whom neither biopsy nor ≥6 months of follow-up imaging has been performed for lesions suspicious for distant metastases
- Pregnant or breastfeeding women. The following cases are considered not at risk of pregnancy: (1) physiologically postmenopausal (no menses for ≥2 years), (2) surgically sterile (history of bilateral oophorectomy or...
- people with serious and/or uncontrolled and/or unstable medical conditions (e.g., congestive heart failure, acute myocardial infarction, severe pulmonary disease, chronic kidney disease, or chronic liver disease)
- people who are relatives or students of the investigator, or otherwise in a dependent relationship with the investigator
- people who, in the judgment of the investigator, are unable to provide complete data for the clinical trial due to personal circumstances or other reasons
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.