FDG PET-CT in Advanced Breast Cancer

NCT ID: NCT07173868

Last Updated: 2025-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-25

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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F-18 FDG PET-CT in advanced breast cancer

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. 19 years of age or older
2. histologically confirmed metastatic or locally advanced breast cancer with no radical topical treatment available
3. If there is liver metastasis, which the researcher believes will be difficult to evaluate the response accurately with bone metastasis or CT
4. May or may not have measurable lesions in accordance with RECIST 1.1 criteria
5. 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
6. Patients scheduled to start primary systemic therapy for advanced breast cancer (endocrine therapy, targeted therapy, chemotherapy, immunotherapy or their combination therapy)
7. 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
8. ECOG Performance Status 0-2

Exclusion Criteria

1. a patient who has previously received systemic treatment for advanced breast cancer
2. 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)
3. Pregnancy or lactation
4. At the same time, other primary malignancies (except when treatment has been completed for radical purposes) are known
5. Other medical conditions that, at the discretion of the researcher, may hinder participation in the study or affect the interpretation of the results
6. If you are unable to follow a research procedure or follow-up
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Yeon Hee Park

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Samsung medical Center

Seoul, Gannam-gu, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Yeon Hee Park, phD

Role: CONTACT

+82-2-3410-1780

jungmin Lee, CRC

Role: CONTACT

+82-2-2148-7609

Other Identifiers

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2025-06-039

Identifier Type: -

Identifier Source: org_study_id

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