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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorAsan Medical Center

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Fluoroestradiol (18F)

Treatment groups

85 Participants
are divided into 1 treatment group

Sponsors and collaborators