Diagnostic Performance of [18F]FES PET/CT for Axillary LN Metastasis in ER-positive Breast Cancer

NCT06695039 | Completed Phase 2

• 1 other identifier: FES axilla
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer Invasive

Keywords

breast caner; estrogen receptor; [18F]FES PET/CT; axillary lymph node

Outcome Measures

Primary Outcomes (1)

• 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

  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

  80-100 minutes

• Patient based sensitivity, specificity, area under ROC curve of quantitative [18F]FES PET/CT evaluation for axillary lymph node metastasis

  80-100 minutes

• Detection rate of qualitative [18F]FES PET/CT evaluation for cN3 lymph node metastasis

  80-100 minutes

• Detection rate of qualitative [18F]FES PET/CT evaluation for distant metastasis

  80-100 minutes

Study Arms (1)

[18F]FES PET/CT

EXPERIMENTAL

Diagnostic Test: Fluoroestradiol (18F)

Interventions

Fluoroestradiol (18F) DIAGNOSTIC_TEST

images for 90 minutes after F-18 FES injection

[18F]FES PET/CT

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

Study Officials

• Sangwon Han, Clinical assistant professor

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical assistant professor

Model Details: A phase 2, open-label, non-randomized, single center study

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: November 19, 2024
• Study Start: November 18, 2024
• Primary Completion: October 2, 2025
• Study Completion: October 2, 2025
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)