Actively Recruiting

Age: 19Years +
All Genders
NCT07173868

FDG PET-CT in Advanced Breast Cancer

Led by Samsung Medical Center · Updated on 2025-09-15

100

Participants Needed

1

Research Sites

127 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

FDG PET-CT in Advanced Breast Cancer

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 19 years of age or older
  • Histologically confirmed metastatic or locally advanced breast cancer with no radical topical treatment available
  • If liver metastasis is present and response evaluation is difficult with bone metastasis or CT
  • Presence or absence of measurable lesions according to RECIST 1.1 criteria
  • Eligible for F-18 FDG PET-CT tests for treatment response evaluation per Health Insurance Review and Assessment Service
  • Scheduled to start first systemic therapy for advanced breast cancer including endocrine, targeted, chemotherapy, immunotherapy, or combinations
  • Willing to undergo continuous response assessments using F-18 FDG PET-CT and CE-CT (± bone scan) before treatment and at 6, 12, 24, 48 weeks after treatment
  • ECOG Performance Status 0-2
Not Eligible

You will not qualify if you...

  • Previous systemic treatment for advanced breast cancer
  • Contraindications to 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
  • Other primary malignancies unless treatment completed for radical purposes
  • Medical conditions that may hinder participation or affect result interpretation
  • Inability to comply with study procedures or follow-up

AI-Screening

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Trial Site Locations

Total: 1 location

1

Samsung medical Center

Seoul, Gannam-gu, South Korea, 06351

Actively Recruiting

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Research Team

Y

Yeon Hee Park, phD

CONTACT

J

jungmin Lee, CRC

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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