Metastatic Breast Cancer
Conditions
Keywords
Metastatic breast cancer, whole body magnetic resonance imaging
Brief summary
This is a non randomized, single arm study, where each patient will undergo imaging with Computed Tomography (CT) and Whole-body magnetic resonance imaging (WB-MRI) at different timepoint. The primary endpoint is time to progression as documented by CT or WB-MRI.
Detailed description
This is a monocentric study. All patients will undergo assessments by CT and WB-MRI at all time points. * A baseline bone scan or Fluorodeoxyglucose-Position Emission Tomography (FDG-PET) will be performed. * CT scans and WB--MRI are performed every 12 weeks until week 96, and then every 24 weeks until disease progression is evident (as defined in section 7.1.3). * At the point of disease progression, a repeat bone scan or FDG-PET/CT will be obtained in addition to the CT and WB-MRI. Participation in the trials ends at the point of disease progression. Patients will be reviewed in outpatient clinic: * At baseline * Every 12 weeks until week 96, with the results of their recent scans. * As with the imaging, the trial visits will change to every 24 weeks after the week 96 visit. At the week 12 and week 36 visits, the patients will undergo a clinical examination and perform a pain thermometer score and Patient Imaging Questionnaire.
Interventions
OTHERWB-MRI
All patients will undergo a CT scan (neck/thorax/abdomen/pelvis) and a WB-MRI
Sponsors
European Institute of Oncology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histological diagnosis of breast cancer * Single or multiple bone metastases (additional extraosseous or non-bony metastatic disease permitted) * Due to start a new line of either hormone therapy or chemotherapy (use of bisphosphonates / denosumab or targeted agents e.g. trastuzumab in addition to hormone therapy / chemotherapy permitted) * Aged 18 and over * Life expectancy of over 6 months * No current active malignancy other than breast cancer
Exclusion criteria
* Radical treatment to sole site of metastatic disease e.g. Cyberknife to solitary bone metastasis * Absolute contraindication to MRI studies, CT scans, bone scans or FDG-PET/CT * Pregnancy * Psychological, familial, sociological or geographical conditions that would hamper compliance with the study protocol; such conditions should be discussed with the patient as part of the informed consent process.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of disease progression in bone metastasis identified by WB-MRI prior to CT scan | 36 months | Number of patients where disease progression in bone metastases were identified using WB-MRI prior to identification by CT scan |
Countries
Italy
Outcome results
None listed