[18F]FES PET/CT for the Detection of Distant Metastasis in Low-grade ER-positive Stage III Breast Cancer

NCT07314073 | Recruiting Phase 2

• 1 other identifier: FES LABC
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the detection rate of distant metastases using \[18F\]FES PET/CT in patients with low-grade, ER-positive stage III breast cancer.

Conditions

Stage III Breast Cancer

Keywords

breast cancer; estrogen receptor; [18F]FES PET/CT; distant metastasis

Outcome Measures

Primary Outcomes (1)

• Patient based detection rate of qualitative [18F]FES PET/CT evaluation for distant metastases

  Baseline (index [18F]FES PET/CT image interpretation performed within 1 week after PET/CT acquisition, prior to initiation of definitive treatment)

Secondary Outcomes (6)

• Patient-based sensitivity and specificity of qualitative [18F]FES PET/CT evaluation for distant metastases

  From baseline [18F]FES PET/CT to confirmation of reference standard, assessed up to 6 months (histopathologic confirmation or clinical and imaging follow-up ≥6 months, through multidisciplinary consensus review)

• Patient-based detection rate of qualitative [18F]FES PET/CT evaluation for cN3 lymph node metastases

  Baseline (index [18F]FES PET/CT image interpretation performed within 1 week after PET/CT acquisition, prior to initiation of definitive treatment)

• Patient-based sensitivity and specificity of qualitative [18F]FES PET/CT evaluation for cN3 lymph node metastases

  From baseline [18F]FES PET/CT to confirmation of reference standard, assessed up to 6 months (histopathologic confirmation or clinical and imaging follow-up ≥6 months, through multidisciplinary consensus review)

• Patient-based change rate in clinical management based on qualitative 18F-FES PET/CT evaluation

  From baseline clinical management plan (pre-[18F]FES PET/CT) to final treatment decision after [18F]FES PET/CT, assessed within 4 weeks after PET/CT

• Comparative patient-based evaluation of qualitative [18F]FES PET/CT and [18F]FDG PET/CT for detection rate of distant and cN3 lymph node metastases, and rate of change in clinical management

  Baseline (paired [18F]FES PET/CT and [18F]FDG PET/CT image interpretation performed within 1 week after each PET/CT acquisition)

Other Outcomes (1)

• Correlation between qualitative/quantitative [18F]FES PET/CT evaluation and response to neoadjuvant chemotherapy

  From baseline [18F]FES PET/CT to post-surgical pathologic response assessment after completion of neoadjuvant chemotherapy, assessed up to 12 months

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 patients aged ≥19 years, regardless of race/ethnicity
• Patients newly diagnosed with invasive breast cancer within 90 days prior to screening, with documented histopathological confirmation.
• Patients diagnosed with histologically confirmed estrogen receptor-positive, histologic grade 1 or 2 primary breast cancer
• Patients with clinical stage IIIA-IIIC disease according to the 8th edition of the American Joint Committee on Cancer (AJCC) TNM staging system
• Patients who have undergone, or are scheduled to undergo chest computed tomography (CT), abdominal CT, and bone scintigraphy within 90 days prior to screening before the 18F-FES PET/CT scan
• Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of ≤2

You may not qualify if:

• The subject or the subject's legally authorized representative has not signed the informed consent form
• Subjects who are currently receiving systemic therapy for breast cancer (e.g., neoadjuvant chemotherapy, hormonal therapy)
• Subjects with a history of another invasive malignancy within the past 2 years (except for non-melanoma skin cancer)
• Subjects diagnosed with distant metastases on chest CT, abdominal CT, or bone scintigraphy performed within 90 days prior to screening or before the 18F-FES PET/CT scan
• Subjects for whom neither biopsy nor ≥6 months of follow-up imaging has been performed for lesions suspicious for distant metastases
• Pregnant or breastfeeding women. The following cases are considered not at risk of pregnancy: (1) physiologically postmenopausal (no menses for ≥2 years), (2) surgically sterile (history of bilateral oophorectomy or hysterectomy), (3) women of childbearing potential with a documented negative serum or urine pregnancy test within 24 hours prior to 18F-FES administration, and who agree to use effective contraception during the trial.
• Subjects with serious and/or uncontrolled and/or unstable medical conditions (e.g., congestive heart failure, acute myocardial infarction, severe pulmonary disease, chronic kidney disease, or chronic liver disease)
• Subjects who are relatives or students of the investigator, or otherwise in a dependent relationship with the investigator
• Subjects who, in the judgment of the investigator, are unable to provide complete data for the clinical trial due to personal circumstances or other reasons

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Hyehyun Jeong

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sangwon Han

CONTACT

+82-2-3010-0657; hswon87@amc.seoul.kr

Jaeeun Kim

CONTACT

+82-2-3010-4572; kje0216@amc.seoul.kr

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: Assistant professor

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

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: January 2, 2026
• Study Start: December 24, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)