Carcinoma, LobularPhase 2NCT05960201
Diagnostic Performance of [18F]FES PET/CT for Axillary LN Metastasis in Invasive Lobular Carcinoma
A Phase 2 study testing [18F]fluoroestradiol (FES) in people with Carcinoma, Lobular, run by Asan Medical Center at 1 site in South Korea.
Trial summary
This study aims to explore the diagnostic validity of [18F]FES PET/CT for the evaluation of axillary lymph node metastasis in patients with invasive lobular 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
- Carcinoma, Lobular
- What is being tested?
- [18F]fluoroestradiol (FES)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Aug 2023to 20 Aug 2024
- 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 estrogen receptor-positive invasive lobular 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 axillay 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 large, bulky, matted cN2 or cN3 axillary lymph node metastases, or 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 the Diagnostic Performance of [18F]FES PET/CT for the Assessment of Axillary Lymph Node Metastasis in Invasive Lobular Carcinoma of the Breast
This study aims to explore the diagnostic validity of [18F]FES PET/CT for the evaluation of axillary lymph node metastasis in patients with invasive lobular breast cancer having clinically suspected or confirmed axillary lymph node metastasis.
Read the detailed description
Invasive lobular carcinoma (ILC) is known to account for about 10-15% of all invasive breast cancer and is the second most common subtype of breast cancer following invasive ductal carcinoma (IDC). ILC is histologically characterized by the loss of E-cadherin involved in cell adhesion, which contributes to the growth and infiltration of tumors in the characteristic non-adhesive single cell layer pattern of ILC]. Therefore, ILC often has no tumors detected by physical examinations and the sensitivity of mammography being reported to be 34%, which is much lower than IDC (81%). Therefore, the diagnosis of ILC is often delayed, the tumor size is larger and the stage is higher than that of IDC at the first visit. The diagnostic accuracy of breast ultrasound for axillary lymph node metastasis is reported as 55-92% for sensitivity and 80-97% for specificity. However, in the case of ILC, the diagnostic performance is significantly lower than this. According to the previous study on ILC, mammography had 7% of sensitivity, ultrasound had 26%, and MRI had 7% in diagnosing axillary lymph node metastasis with 38% of patients having false positive results for axillary lymph node metastasis. This is related to ILC-specific metastasis patterns in which only cells are replaced by cancer cells while maintaining the normal structure of the lymph node and the absence of desmoplastic reaction. The NCCN guideline recommends that during axillary lymph node resection, resection is performed up to level III if lymph node metastasis is confirmed or suspected in axillary level II or III. Preoperative chemotherapy should be considered for lymph node metastasis of cN3 or Bulky or matted cN2 stage. Considering the limited diagnostic accuracy of those standard imaging tests for diagnosis of axillary lymph node metastasis, [18F]FES PET/CT may help change treatment strategy, such as changing the extent of axillary lymph node resection or performing neoadjuvant chemotherapy instead of upfront surgery in patients with ILC. In addition, considering that high rate of distant metastasis and limited diagnostic accuracy of preexisting imaging modality in ILC, [18F]FES PET/CT is likely to help treatment decision making by discovering unexpected distant metastases. It is reported that the implementation of [18F]FES PET/CT contributed to the change in treatment policy in about 26% of patients compared to conventional standard imaging and [18F]FDG PET/CT. Currently in South Korea, reimbursement of [18F]FES PET/CT is limited to patients with recurrent or metastatic breast cancer whose lesions are located in the cervical spine, upper thoracic, pelvic, peritoneum, pleural, and mediastinal lymph nodes.
- Conditions
- Carcinoma, Lobular
- Being tested
- [18F]fluoroestradiol (FES)
- Medical subject headings
- Carcinoma, Lobular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]fluoroestradiol (FES)Drug
F-18 FES 111~222 MBq(megabecquerel) injection
| Study group | Role | What they receive |
|---|---|---|
| invasive lobular breast cancer | Experimental | images for 90 minutes after F-18 FES injection Receives: Drug: [18F]fluoroestradiol (FES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient based sensitivity, specificity, positive predictive and negative predictive values of a qualitative [18F]FES PET/CT assessment of axillary lymph node metastasis
diagnostic accuracy of qualitative [18F]FES PET/CT analysis
Measured: 90-120 min
Secondary outcomes (4)
Patient based sensitivity, specificity, positive predictive and negative predictive values of quantitative [ 18 F]FES PET/CT evaluation for axillary lymph node metastasis
diagnostic accuracy of quatitative [18F]FES PET/CT analysis
Measured: 90-120 min
Patient based sensitivity, specificity, positive predictive and negative predictive values of [18F]FES PET/CT in FNA or CNB-negative patients
Subgroup analsis of FNA or CNB-negative patients
Measured: 90-120 min
Detection rate of qualitative [18F]FES PET/CT evaluation for cN3 lymph node metastasis
Unexpected N3 node detection rate
Measured: 90-120 min
Detection rate of qualitative [18F]FES PET/CT evaluation for distant metastasis
Unexpected M1 detection rate
Measured: 90-120 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start10 Aug 2023
- Primary completion20 Aug 2024
- Study completion20 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, LobularStudies 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
- Masking
- None (open label)
- Enrolment
- 23 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, Principal investigator, Clinical assistant professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05960201
- Sponsor's protocol ID
- FES lobular
- Status last verified
- Aug 2024
- First submitted
- 18 Jul 2023
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ryu J, Han S, Yoo TR, Lee SB, Kim J, Kim HJ, Chung IY, Ko BS, Lee JW, Son BH, Lee HJ, Gong G, Moon DH. Diagnostic Performance of 18F-Fluoroestradiol PET/CT for Axillary Lymph Node Metastasis in Invasive Lobular Carcinoma: A Prospective Feasibility Study. J Nucl Med. 2025 Oct 1;66(10):1555-1560. doi: 10.2967/jnumed.125.269573.
PubMed 40813238
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. 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 the Diagnostic Performance of [18F]FES PET/CT for the Assessment of Axillary Lymph Node Metastasis in Invasive Lobular Carcinoma of the Breast
- ClinicalTrials.gov ID
- NCT05960201
- Acronym / sponsor ID
- FES lobular
- Conditions
- Carcinoma, Lobular
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 10 Aug 2023 (actual)
- Primary completion
- 20 Aug 2024 (actual)
- Study completion
- 20 Aug 2024 (actual)
- First posted
- 25 Jul 2023 (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 validity of [18F]FES PET/CT for the evaluation of axillary lymph node metastasis in patients with invasive lobular breast cancer having clinically suspected or confirmed axillary lymph node metastasis.
Detailed description
Invasive lobular carcinoma (ILC) is known to account for about 10-15% of all invasive breast cancer and is the second most common subtype of breast cancer following invasive ductal carcinoma (IDC). ILC is histologically characterized by the loss of E-cadherin involved in cell adhesion, which contributes to the growth and infiltration of tumors in the characteristic non-adhesive single cell layer pattern of ILC]. Therefore, ILC often has no tumors detected by physical examinations and the sensitivity of mammography being reported to be 34%, which is much lower than IDC (81%). Therefore, the diagnosis of ILC is often delayed, the tumor size is larger and the stage is higher than that of IDC at the first visit. The diagnostic accuracy of breast ultrasound for axillary lymph node metastasis is reported as 55-92% for sensitivity and 80-97% for specificity. However, in the case of ILC, the diagnostic performance is significantly lower than this. According to the previous study on ILC, mammography had 7% of sensitivity, ultrasound had 26%, and MRI had 7% in diagnosing axillary lymph node metastasis with 38% of patients having false positive results for axillary lymph node metastasis. This is related to ILC-specific metastasis patterns in which only cells are replaced by cancer cells while maintaining the normal structure of the lymph node and the absence of desmoplastic reaction. The NCCN guideline recommends that during axillary lymph node resection, resection is performed up to level III if lymph node metastasis is confirmed or suspected in axillary level II or III. Preoperative chemotherapy should be considered for lymph node metastasis of cN3 or Bulky or matted cN2 stage. Considering the limited diagnostic accuracy of those standard imaging tests for diagnosis of axillary lymph node metastasis, [18F]FES PET/CT may help change treatment strategy, such as changing the extent of axillary lymph node resection or performing neoadjuvant chemotherapy instead of upfront surgery in patients with ILC. In addition, considering that high rate of distant metastasis and limited diagnostic accuracy of preexisting imaging modality in ILC, [18F]FES PET/CT is likely to help treatment decision making by discovering unexpected distant metastases. It is reported that the implementation of [18F]FES PET/CT contributed to the change in treatment policy in about 26% of patients compared to conventional standard imaging and [18F]FDG PET/CT. Currently in South Korea, reimbursement of [18F]FES PET/CT is limited to patients with recurrent or metastatic breast cancer whose lesions are located in the cervical spine, upper thoracic, pelvic, peritoneum, pleural, and mediastinal lymph nodes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| invasive lobular breast cancer | Experimental | Drug: [18F]fluoroestradiol (FES)images for 90 minutes after F-18 FES injection |
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 estrogen receptor-positive invasive lobular 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 axillay 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 large, bulky, matted cN2 or cN3 axillary lymph node metastases, or 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 |
|---|---|---|
| [18F]fluoroestradiol (FES)F-18 FES 111~222 MBq(megabecquerel) injection | Drug | invasive lobular breast cancer |
Primary outcome
Patient based sensitivity, specificity, positive predictive and negative predictive values of a qualitative [18F]FES PET/CT assessment of axillary lymph node metastasis
Time frame: 90-120 min
diagnostic accuracy of qualitative [18F]FES PET/CT analysis
4 secondary outcomes
Patient based sensitivity, specificity, positive predictive and negative predictive values of quantitative [ 18 F]FES PET/CT evaluation for axillary lymph node metastasis
Time frame: 90-120 min
Patient based sensitivity, specificity, positive predictive and negative predictive values of [18F]FES PET/CT in FNA or CNB-negative patients
Time frame: 90-120 min
Detection rate of qualitative [18F]FES PET/CT evaluation for cN3 lymph node metastasis
Time frame: 90-120 min
Detection rate of qualitative [18F]FES PET/CT evaluation for distant metastasis
Time frame: 90-120 min
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 21 Aug 2024.
- Derived from this study: PubMed 40813238Ryu J, Han S, Yoo TR, Lee SB, Kim J, Kim HJ, Chung IY, Ko BS, Lee JW, Son BH, Lee HJ, Gong G, Moon DH. Diagnostic Performance of 18F-Fluoroestradiol PET/CT for Axillary Lymph Node Metastasis in Invasive Lobular Carcinoma: A Prospective Feasibility Study. J Nucl Med. 2025 Oct 1;66(10):1555-1560. doi: 10.2967/jnumed.125.269573.
- 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 principal investigator
Clinical assistant professor
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 [18F]fluoroestradiol (FES) in people with Carcinoma, Lobular, 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 21 Aug 2024. 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, specificity, positive predictive and negative predictive values of a qualitative [18F]FES PET/CT assessment of axillary lymph node metastasis (time frame: 90-120 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05960201, which also lists 1 linked publication.
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 21 Aug 2024.