Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05730608

18F-FDG PET/CT Imaging for Breast Cancer

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:

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Drammen Hospital - Vestre Viken HF

Drammen, N-3004, Norway

Location status: Recruiting

Location contact

Harald Grut, MD, PHD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

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

Treatment and study plan

18F-FDG PET/CT

Other

Included breast cancer patients will undergo a 18F-FDG PET/CT scan in addition to conventional imaging with CT and bone scintigraphy.

Primary outcomes

  1. Change in staging and/or management due to added 18F-FDG PET/CT scan

    Time frame: 5 years

    Percentage of the patients with change in staging and/or management

Secondary outcomes

  1. Overall survival

    Time frame: 5 years

    Survival after 18F-FDG PET/CT scan

Study contacts

Contact information is provided by the study sponsor or research team.

Harald Grut, MD, PHD

CONTACT

[email protected]

004797108503

Sponsors and collaborators

Lead sponsor

Vestre Viken Hospital Trust

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2032
Study completion
2032
First posted
Feb 16, 2023
Registry last updated
May 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.