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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Norway
Drammen Hospital - Vestre Viken HF
RECRUITING
Drammen
Contact Information
Primary
Harald Grut, MD, PHD
harald.grut@gmail.com
004797108503
Time Frame
Start Date: 2023-02-16
Estimated Completion Date: 2032-12-31
Participants
Target number of participants: 300
Treatments
Other: Primary breast cancer
Patients diagnosed with new breast cancer determined to have high risk disease by a multidisciplinary team.
Other: Recurrent breast cancer
Patients with suspected or proven locoregional recurrent breast cancer.
Related Therapeutic Areas
Sponsors
Leads: Vestre Viken Hospital Trust

This content was sourced from clinicaltrials.gov