Breast Cancer InvasivePhase 2NCT06695039
Diagnostic Performance of [18F]FES PET/CT for Axillary LN Metastasis in ER-positive Breast Cancer
A Phase 2 study testing Fluoroestradiol (18F) in people with Breast Cancer Invasive, run by Asan Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Breast Cancer Invasive
- What is being tested?
- Fluoroestradiol (18F)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Nov 2024to 2 Oct 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
Breast cancer is the most common cancer among women, with around 310,000 new cases expected in the U.S. in 2024, accounting for 32% of all cancers diagnosed in women. About 75% of breast cancers express estrogen receptors (ER) at the time of diagnosis, and the axillary lymph nodes are the most common site for metastasis. Around 34% of breast cancer patients present with lymph node metastasis, with 24% classified as pN1 (1-3 lymph nodes) and 10% as pN2 or higher (4 or more lymph nodes) according to the AJCC staging system. The presence and extent of lymph node metastasis are critical in determining the stage of breast cancer, as well as predicting the likelihood of recurrence and survival after surgery. Lymph node involvement also guides decisions about the scope of surgery and systemic therapy.
To minimize complications such as lymphedema, axillary lymph node dissection (ALND) has become less invasive over time. The ACOSOG Z0011 trial demonstrated that patients with 1-2 lymph node metastases detected via sentinel node biopsy (SNB), who had no clinically evident axillary lymph node metastasis, could avoid ALND without negatively affecting their prognosis. As a result, preoperative evaluation of axillary lymph node metastasis has become increasingly important in determining the appropriate surgical approach. For systemic treatment, the NCCN guidelines recommend adjuvant chemotherapy for estrogen receptor-positive, HER2-negative breast cancer patients with pN2 or higher lymph node involvement after surgery. In cases of pN1 or pN0 (with tumors larger than 0.5 cm), the decision to administer adjuvant chemotherapy is based on the recurrence risk score from a 21-gene assay.
[18F]FES PET/CT has recently gained attention as an imaging modality for breast cancer due to its ability to evaluate ER status with high concordance to immunohistochemistry and detect metastasis. The NCCN guidelines now recommend its use in cases of recurrent or metastatic ER-positive breast cancer. In our previous research, [18F]FES PET/CT has a sensitivity of 77% and specificity of 100% for breast cancer diagnosis when compared to histopathological findings. Although its accuracy for detecting axillary lymph node metastasis specifically has not been thoroughly studied, it has shown potential in identifying difficult-to-detect axillary metastases. In one study, the use of [18F]FES PET/CT led to changes in treatment plans for about 26% of patients, particularly by identifying lymph node metastases that were missed by standard imaging techniques.
In addition to its use in recurrent or metastatic breast cancer, [18F]FES PET/CT is being investigated for its utility in evaluating axillary lymph nodes and staging early breast cancer. Preliminary studies at our hospital on invasive lobular breast cancer patients have shown that [18F]FES PET/CT has favorable diagnostic accuracy for detecting axillary lymph node metastasis. While PET resolution limits its ability to assess micrometastases, the high specificity and positive predictive value suggest that it could accurately predict the presence and burden of axillary lymph node metastasis in estrogen receptor-positive breast cancer.
- Conditions
- Breast Cancer Invasive
- Being tested
- Fluoroestradiol (18F)
- Keywords
- breast caner, estrogen receptor, [18F]FES PET/CT, axillary lymph node
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoroestradiol (18F)Diagnostic test
images for 90 minutes after F-18 FES injection
| Study group | Role | What they receive |
|---|---|---|
| [18F]FES PET/CT | Experimental | Not described Receives: Diagnostic Test: Fluoroestradiol (18F) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient based sensitivity and specificity of qualitative [18F]FES PET/CT evaluation for axillary lymph node metastasis
diagnostic accuracy of qualitative [18F]FES PET/CT analysis
Measured: 80-100 minutes
Secondary outcomes (4)
Patient based sensitivity and specificity of qualitative [18F]FES PET/CT evaluation for pN2/3 axillary lymph node metastasis
diagnostic accuracy of qualitative [18F]FES PET/CT analysis of pN2/3 axillary LN metastasis
Measured: 80-100 minutes
Patient based sensitivity, specificity, area under ROC curve of quantitative [18F]FES PET/CT evaluation for axillary lymph node metastasis
diagnostic accuracy of quantitative [18F]FES PET/CT analysis
Measured: 80-100 minutes
Detection rate of qualitative [18F]FES PET/CT evaluation for cN3 lymph node metastasis
Unexpected N3 node detection rate
Measured: 80-100 minutes
Detection rate of qualitative [18F]FES PET/CT evaluation for distant metastasis
Unexpected M1 detection rate
Measured: 80-100 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start18 Nov 2024
- Primary completion2 Oct 2025
- Study completion2 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer InvasiveStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A phase 2, open-label, non-randomized, single center study
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sangwon Han, Asan Medical Center
- Investigators
- Sangwon Han, Clinical assistant professor, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06695039
- Sponsor's protocol ID
- FES axilla
- Status last verified
- Nov 2025
- First submitted
- 24 Sep 2024
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06695039
- Acronym / sponsor ID
- FES axilla
- Conditions
- Breast Cancer Invasive
- Keywords
- breast caner, estrogen receptor, [18F]FES PET/CT, axillary lymph node
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- 2 Oct 2025 (actual)
- Study completion
- 2 Oct 2025 (actual)
- First posted
- 19 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Breast cancer is the most common cancer among women, with around 310,000 new cases expected in the U.S. in 2024, accounting for 32% of all cancers diagnosed in women. About 75% of breast cancers express estrogen receptors (ER) at the time of diagnosis, and the axillary lymph nodes are the most common site for metastasis. Around 34% of breast cancer patients present with lymph node metastasis, with 24% classified as pN1 (1-3 lymph nodes) and 10% as pN2 or higher (4 or more lymph nodes) according to the AJCC staging system. The presence and extent of lymph node metastasis are critical in determining the stage of breast cancer, as well as predicting the likelihood of recurrence and survival after surgery. Lymph node involvement also guides decisions about the scope of surgery and systemic therapy.
To minimize complications such as lymphedema, axillary lymph node dissection (ALND) has become less invasive over time. The ACOSOG Z0011 trial demonstrated that patients with 1-2 lymph node metastases detected via sentinel node biopsy (SNB), who had no clinically evident axillary lymph node metastasis, could avoid ALND without negatively affecting their prognosis. As a result, preoperative evaluation of axillary lymph node metastasis has become increasingly important in determining the appropriate surgical approach. For systemic treatment, the NCCN guidelines recommend adjuvant chemotherapy for estrogen receptor-positive, HER2-negative breast cancer patients with pN2 or higher lymph node involvement after surgery. In cases of pN1 or pN0 (with tumors larger than 0.5 cm), the decision to administer adjuvant chemotherapy is based on the recurrence risk score from a 21-gene assay.
[18F]FES PET/CT has recently gained attention as an imaging modality for breast cancer due to its ability to evaluate ER status with high concordance to immunohistochemistry and detect metastasis. The NCCN guidelines now recommend its use in cases of recurrent or metastatic ER-positive breast cancer. In our previous research, [18F]FES PET/CT has a sensitivity of 77% and specificity of 100% for breast cancer diagnosis when compared to histopathological findings. Although its accuracy for detecting axillary lymph node metastasis specifically has not been thoroughly studied, it has shown potential in identifying difficult-to-detect axillary metastases. In one study, the use of [18F]FES PET/CT led to changes in treatment plans for about 26% of patients, particularly by identifying lymph node metastases that were missed by standard imaging techniques.
In addition to its use in recurrent or metastatic breast cancer, [18F]FES PET/CT is being investigated for its utility in evaluating axillary lymph nodes and staging early breast cancer. Preliminary studies at our hospital on invasive lobular breast cancer patients have shown that [18F]FES PET/CT has favorable diagnostic accuracy for detecting axillary lymph node metastasis. While PET resolution limits its ability to assess micrometastases, the high specificity and positive predictive value suggest that it could accurately predict the presence and burden of axillary lymph node metastasis in estrogen receptor-positive breast cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A phase 2, open-label, non-randomized, single center study
| Arm | Type | Receives |
|---|---|---|
| [18F]FES PET/CT | Experimental | Diagnostic Test: Fluoroestradiol (18F) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluoroestradiol (18F)images for 90 minutes after F-18 FES injection | Diagnostic test | [18F]FES PET/CT |
Primary outcome
Patient based sensitivity and specificity of qualitative [18F]FES PET/CT evaluation for axillary lymph node metastasis
Time frame: 80-100 minutes
diagnostic accuracy of qualitative [18F]FES PET/CT analysis
4 secondary outcomes
Patient based sensitivity and specificity of qualitative [18F]FES PET/CT evaluation for pN2/3 axillary lymph node metastasis
Time frame: 80-100 minutes
Patient based sensitivity, specificity, area under ROC curve of quantitative [18F]FES PET/CT evaluation for axillary lymph node metastasis
Time frame: 80-100 minutes
Detection rate of qualitative [18F]FES PET/CT evaluation for cN3 lymph node metastasis
Time frame: 80-100 minutes
Detection rate of qualitative [18F]FES PET/CT evaluation for distant metastasis
Time frame: 80-100 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sangwon Han, Clinical assistant professor principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluoroestradiol (18F) in people with Breast Cancer Invasive, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient based sensitivity and specificity of qualitative [18F]FES PET/CT evaluation for axillary lymph node metastasis (time frame: 80-100 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.