RecruitingNCT07173868

FDG PET-CT in Advanced Breast Cancer

A Prospective Cohort Study Comparing Metabolic Response Evaluation by F-18 FDG PET-CT Versus Conventional Imaging for Outcome Stratification in Patients With Advanced Breast Cancer Receiving First-line Systemic Therapy

Sponsor

Samsung Medical Center

Enrollment

100 participants

Start Date

Jul 25, 2025

Study Type

OBSERVATIONAL

Conditions

Histologically Confirmed Metastatic or Locally Advanced Breast Cancer With no Radical Topical Treatment Available If There is Liver Metastasis, Which the Researcher Believes Will be Difficult to Evaluate the Response Accurately With Bone Metastasis or CT

Summary

This study is a prospective cohort study comparing metabolic response evaluation by F-18 FDG PET-CT versus conventional imaging for outcome stratification in patients with advanced breast cancer receiving first-line systemic therapy.

Eligibility

Min Age: 19 Years

Inclusion Criteria8

years of age or older
histologically confirmed metastatic or locally advanced breast cancer with no radical topical treatment available
If there is liver metastasis, which the researcher believes will be difficult to evaluate the response accurately with bone metastasis or CT
May or may not have measurable lesions in accordance with RECIST 1.1 criteria
Patients who meet the criteria for coverage of F-18 FDG PET-CT tests conducted for the purpose of evaluating treatment response according to the Health Insurance Review and Assessment Service's announcement
Patients scheduled to start primary systemic therapy for advanced breast cancer (endocrine therapy, targeted therapy, chemotherapy, immunotherapy or their combination therapy)
Patients willing to undergo continuous response assessments using F-18 FDG PET-CT and CE-CT (± bone scan if clinically necessary) at the time point specified in the study plan (before treatment, 6, 12, 24, 48 weeks after treatment) and willing to pay for the examination accordingly
ECOG Performance Status 0-2

Exclusion Criteria6

a patient who has previously received systemic treatment for advanced breast cancer
Taboos for F-18 FDG PET-CT (e.g., uncontrolled diabetes) or intravenous contrast agents for CE-CT (e.g., severe allergies, severe renal dysfunction)
Pregnancy or lactation
At the same time, other primary malignancies (except when treatment has been completed for radical purposes) are known
Other medical conditions that, at the discretion of the researcher, may hinder participation in the study or affect the interpretation of the results
If you are unable to follow a research procedure or follow-up

Locations(1)

Samsung medical Center

Seoul, Gannam-gu, South Korea

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NCT07173868