Breast Cancer Female, Breast Cancer Recurrent
Conditions
Brief summary
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:
Interventions
OTHER18F-FDG PET/CT
Included breast cancer patients will undergo a 18F-FDG PET/CT scan in addition to conventional imaging with CT and bone scintigraphy.
Sponsors
Vestre Viken Hospital Trust
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with high risk primary or recurrent breast cancer * Non pregnant women \> 18 years * Not receiving active treatment of other cancer types. * Eastern Cooperative Oncology Group (ECOG) status 0-2.
Exclusion criteria
* Pregnant woman * Males * Age under 18 * Patients receiving active treatment for other cancers * Poor general conditipon (ECOG 3 or higher)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in staging and/or management due to added 18F-FDG PET/CT scan | 5 years | Percentage of the patients with change in staging and/or management |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 5 years | Survival after 18F-FDG PET/CT scan |
Countries
Norway
Contacts
Primary ContactHarald Grut, MD, PHD
Outcome results
None listed