Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT05730608

18F-FDG PET/CT Imaging for Breast Cancer

Led by Vestre Viken Hospital Trust · Updated on 2024-05-09

300

Participants Needed

1

Research Sites

515 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

18F-FDG PET/CT Imaging for Breast Cancer

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with high risk primary or recurrent breast cancer
  • Non pregnant women over 18 years old
  • Not receiving active treatment of other cancer types
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
Not Eligible

You will not qualify if you...

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

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Trial Site Locations

Total: 1 location

1

Drammen Hospital - Vestre Viken HF

Drammen, Norway, N-3004

Actively Recruiting

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Research Team

H

Harald Grut, MD, PHD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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