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18F-FDG PET/CT Imaging for Breast Cancer

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…

ClinicalTrials.gov IDNCT05730608
PhaseNA
Enrollment300
SponsorVestre Viken Hospital Trust
Age18 Years
SexFEMALE
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Conditions studied

Breast Cancer Female, Breast Cancer Recurrent

About this study

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

Primary outcomes

Eligibility information

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)

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.