RecruitingNot ApplicableNCT05730608

18F-FDG PET/CT Imaging for Breast Cancer

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


Sponsor

Vestre Viken Hospital Trust

Enrollment

300 participants

Start Date

Feb 16, 2023

Study Type

INTERVENTIONAL

Conditions

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:


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria4

  • 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 Criteria5

  • Pregnant woman
  • Males
  • Age under 18
  • Patients receiving active treatment for other cancers
  • Poor general conditipon (ECOG 3 or higher)

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.


Locations(1)

Drammen Hospital - Vestre Viken HF

Drammen, Norway

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NCT05730608


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