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

Plain Language Summary

Simplified for easier understanding

This study is evaluating whether PET/CT scanning using a radiotracer called 18F-FDG can improve staging and monitoring for women with high-risk or recurrent breast cancer. PET/CT gives a full-body picture of metabolically active tissue and may detect cancer spread that other scans miss. **You may be eligible if...** - You are a woman over 18 years old - You have high-risk primary breast cancer or recurrent breast cancer - You are not pregnant - You are not actively being treated for another type of cancer - Your general health is reasonably good (ECOG 0–2) **You may NOT be eligible if...** - You are pregnant - You are being actively treated for another cancer at the same time - Your general health is poor (ECOG 3 or higher) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05730608


Related Trials