Actively Recruiting
18F-FDG PET/CT Imaging for Breast Cancer
Led by Vestre Viken Hospital Trust · Updated on 2024-05-09
300
Participants Needed
1
Research Sites
515 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Purpose To investigate the ability of 18F-FDG PET/CT imaging to detect metastases not detected by conventional imaging (CT and bone scintigraphy) in patients diagnosed with stage II/III and locoregional recurrent breast cancer (BC) which can affect the choice of treatment. Hypothesis The hypothesis is that 18F-FDG PET/CT can provide information about disease stage beyond the currently used conventional imaging (CT and bone scintigraphy) in patients diagnosed with stage II/III or locoregional recurrent BC. Objectives Primary: To evaluate if a 18F-FDG PET/CT scan in the initial work up of patients diagnosed with stage II/III or locoregional recurrent BC will lead to change in staging and/or treatment. Secondary: * Overall survival (OS) and progression-free survival (PFS) in the patients with upstaging based on findings on 18F-FDG PET/CT scan compared with the patients with unchanged stage of disease following 18F-FDG PET/CT. * Obtain size of the primary BC from CT/MRI scan and evaluate if these metrics are correlated to outcome. * Obtain PET parameters from the primary BC: maximum, mean, and peak standardized uptake value (SUVmax, SUVmean, SUVpeak), metabolic tumour volume (MTV), total lesion glycolysis (TLG), total MTV and total TLG and evaluate if these metrics are correlated with outcome. * Obtain CT and PET texture parameters from the primary BC and evaluate if these metrics are correlated with outcome. * Blood and tumor samples for molecular characterisation:
CONDITIONS
Official Title
18F-FDG PET/CT Imaging for Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with high risk primary or recurrent breast cancer
- Non pregnant women over 18 years old
- Not receiving active treatment of other cancer types
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
You will not qualify if you...
- Pregnant women
- Males
- Age under 18 years
- Patients receiving active treatment for other cancers
- Poor general condition (ECOG 3 or higher)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Drammen Hospital - Vestre Viken HF
Drammen, Norway, N-3004
Actively Recruiting
Research Team
H
Harald Grut, MD, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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