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NCT Number: NCT07173868

FDG PET-CT in Advanced Breast Cancer

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.

Recruiting

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsung medical Center

Seoul, Gannam-gu, 06351, South Korea

Location status: Recruiting

About this study

PET-CT, CE-CT ± bone scan are performed before and during treatment (6, 12, 24, 48 weeks) of the first systemic treatment in a total of 100 patients with advanced breast cancer, and some patients analyze ctDNA-based MRD by collecting blood at the same time point. We analyze the relationship between patient-specific responses and PFS, and compare the predictive performance of imaging and molecular indicators.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 19 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 criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Follow up the response for 48 weeks after the start of the first systemic treatment

    Time frame: Within 4 weeks prior to the start of primary systemic treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Yeon Hee Park, phD

CONTACT

[email protected]

+82-2-3410-1780

jungmin Lee, CRC

CONTACT

[email protected]

+82-2-2148-7609

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Acronym: PET-000

Important dates

Study start
2025
Primary completion
2025
Study completion
2027
First posted
Sep 15, 2025
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.