Clinical trial · Interventional
Diagnostic Performance of [18F]FES PET/CT for Axillary LN Metastasis in Invasive Lobular Carcinoma
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
NCT05960201CI-TRIAL-00080009completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Lobular | Breast Lobular Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [18F]fluoroestradiol (FES) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- invasive lobular breast cancer
- description
- images for 90 minutes after F-18 FES injection
- interventionNames
- Drug: [18F]fluoroestradiol (FES)
Primary outcomes (1)
- measure
- Patient based sensitivity, specificity, positive predictive and negative predictive values of a qualitative [18F]FES PET/CT assessment of axillary lymph node metastasis
- timeFrame
- 90-120 min
- description
- diagnostic accuracy of qualitative \[18F\]FES PET/CT analysis
Secondary outcomes (4)
- measure
- Patient based sensitivity, specificity, positive predictive and negative predictive values of quantitative [ 18 F]FES PET/CT evaluation for axillary lymph node metastasis
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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). * 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
References
Publications (1)
- DERIVEDRyu 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. PMID 40813238