18F-FDG PET/CT Imaging for Breast Cancer

Not Applicable

Recruiting

• Conditions: Breast Cancer Female; Breast Cancer Recurrent
• Interventions: Other: 18F-FDG PET/CT

• Registration Number: NCT05730608
• Lead Sponsor: Vestre Viken Hospital Trust

Brief 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:

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-27
• Study First Submitted QC: 2023-02-06
• Study Start: 2023-02-16
• Study First Posted: 2023-02-16
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-09
• Primary Completion: 2032-12-31
• Study Completion: 2032-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 300

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Primary breast cancer	18F-FDG PET/CT	Patients diagnosed with new breast cancer determined to have "high risk" disease by a multidisciplinary team.
Recurrent breast cancer	18F-FDG PET/CT	Patients with suspected or proven locoregional recurrent breast cancer.

Primary Outcome Measures

Name	Time	Method
Change in staging and/or management due to added 18F-FDG PET/CT scan	5 years	Percentage of the patients with change in staging and/or management

Secondary Outcome Measures

Name	Time	Method
Overall survival	5 years	Survival after 18F-FDG PET/CT scan

Trial Locations

Locations (1)

Drammen Hospital - Vestre Viken HF; 🇳🇴 Drammen, Norway