18F-FDG PET/CT Imaging for Breast Cancer

Vestre Viken Hospital Trust

Status: Enrolling

Conditions: Breast Cancer Female; Breast Cancer Recurrent

Treatments: Other: 18F-FDG PET/CT

Study type: Interventional

Funder types: Other

Identifiers

NCT05730608

495077

Details and patient eligibility

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:

Enrollment: 300 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

Primary breast cancer

Other group

Description:

Patients diagnosed with new breast cancer determined to have "high risk" disease by a multidisciplinary team.

Treatment:

Other: 18F-FDG PET/CT

Recurrent breast cancer

Other group

Description:

Patients with suspected or proven locoregional recurrent breast cancer.

Treatment:

Other: 18F-FDG PET/CT