NCT05730608

18F-FDG PET/CT Imaging for Breast Cancer

Recruiting now NA Last updated 9 May 2024

What this trial tests

NA trial testing 18F-FDG PET/CT in Breast Cancer Female in 300 participants. Currently enrolling.

Timeline

16 February 2023

Primary endpoint
31 December 2032

31 December 2032

Quick facts

Lead sponsor	Vestre Viken Hospital Trust
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	single
Primary purpose	diagnostic
Enrollment	300
Start date	16 February 2023
Primary completion	31 December 2032
Estimated completion	31 December 2032
Sites	1 location across Norway

Drugs / interventions tested

• 18F-FDG PET/CT — full drug profile →

Conditions studied

• Breast Cancer Female — all drugs for Breast Cancer Female →
• Breast Cancer Recurrent — all drugs for Breast Cancer Recurrent →

Sponsor

Vestre Viken Hospital Trust

Who can join

18 and older, female only, with Breast Cancer Female or Breast Cancer Recurrent. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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:

Publications & conference data

No peer-reviewed publications indexed yet for this trial.