18F-FDG PET/CT Imaging for Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 18F-FDG PET/CT.
- Who it may be relevant to
- Registry conditions: Breast Cancer Female, Breast Cancer Recurrent. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Improving Breast Cancer Staging With 18F-FDG PET/CT Imaging (The IMBRECAS PET Study)
Overview
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:
Interventions
- Other 18F-FDG PET/CT
Included breast cancer patients will undergo a 18F-FDG PET/CT scan in addition to conventional imaging with CT and bone scintigraphy.
Primary outcome measures
- Change in staging and/or management due to added 18F-FDG PET/CT scan [Time frame: 5 years]
Secondary outcome measures (1)
- Overall survival [Time frame: 5 years]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Diagnostic
Study locations
Norway · 1 center
- Drammen Hospital - Vestre Viken HF — Drammen
Identifiers
NCT: NCT05730608 · 495077