New scan could spot breast cancer spread without surgery
NCT ID NCT06695039
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a special PET scan using a radioactive tracer called FES can accurately detect breast cancer that has spread to lymph nodes under the arm. Researchers will scan 71 people with estrogen-positive breast cancer and compare the results to standard methods. If the scan works well, it may help doctors decide on treatment without needing invasive biopsies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Fluoroestradiol (18F) injection
- What this could lead to
- If successful, this could provide a more accurate, non-invasive way to detect breast cancer spread to lymph nodes, potentially reducing unnecessary surgeries.
- What could go wrong
- This is a small, early-phase study (71 people) focused on diagnostic accuracy, not treatment. The results may not apply to all patients or change current practice without larger trials.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
71 people
The number who actually took part.
- Started
-
Nov 2024
- Finished
-
Oct 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
19 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Asan Medical Center
Seoul, South Korea
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Other studies related to the condition(s) this trial covers.
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