18F-FDG PET/CT Imaging for Breast Cancer

Study Overview
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Brief Summary
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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:

Official Title
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Improving Breast Cancer Staging With 18F-FDG PET/CT Imaging (The IMBRECAS PET Study)

Conditions
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Breast Cancer Female, Breast Cancer Recurrent

Intervention / Treatment
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* Other: 18F-FDG PET/CT


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Primary breast cancer<br>Patients diagnosed with new breast cancer determined to have high risk disease by a multidisciplinary team. | Other: 18F-FDG PET/CT<br>* Included breast cancer patients will undergo a 18F-FDG PET/CT scan in addition to conventional imaging with CT and bone scintigraphy.<br>|
| Other: Recurrent breast cancer<br>Patients with suspected or proven locoregional recurrent breast cancer. | Other: 18F-FDG PET/CT<br>* Included breast cancer patients will undergo a 18F-FDG PET/CT scan in addition to conventional imaging with CT and bone scintigraphy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in staging and/or management due to added 18F-FDG PET/CT scan | Percentage of the patients with change in staging and/or management | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Survival after 18F-FDG PET/CT scan | 5 years |