NCT05730608

18F-FDG PET/CT Imaging for Breast Cancer

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Vestre Viken Hospital Trust · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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:

Conditions

• Breast Cancer Female
• Breast Cancer Recurrent

Interventions

Type	Name	Description
OTHER	18F-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.

Timeline

• Start date: 2023-02-16
• Primary completion: 2032-12-31
• Completion: 2032-12-31
• First posted: 2023-02-16
• Last updated: 2024-05-09

Locations

1 site across 1 country: Norway