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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Republic of Korea
Samsung medical Center
RECRUITING
Seoul
Contact Information
Primary
Yeon Hee Park, phD
yeonh.park@samsung.com
+82-2-3410-1780
Backup
jungmin Lee, CRC
jm9356.lee@sbri.co.kr
+82-2-2148-7609
Time Frame
Start Date: 2025-07-25
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 100
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Samsung Medical Center

This content was sourced from clinicaltrials.gov

Similar Clinical Trials