Whole-body MR in Staging Bone and Soft Tissue Metastases in Breast Cancer Patients(MetaMaRBo) (METAMARBO)
Prospective MR-imaging study : role of magnetic resonance (MR) and Diffusion weighted imaging (DWI) MR in staging and therapy assessment in breast cancer patients with bone metastases.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Whole-body Magnetische Resonantie Voor Het Opsporen Van Bot- en Weke Delenmetastasen Bij patiënten Met Een Borstcarcinoom (MetaMaRBo)|
- Validation of whole body diffusion weighted MRI in breastcancer patients [ Time Frame: 6 months ] [ Designated as safety issue: No ]whole body MRI will be correlated to the nucleair bone scan and PET-CT
- Whole body MRI with diffusion weighted imaging is a reliable imaging tool for therapy assessment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||August 2013|
|Estimated Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Breast cancer patients
Breast cancer patients
About 50 patients with a proven breast cancer and bone metastases will be included.
First step : staging
- nuclear bone scan
- Positron Emission Tomography (PET/CT)
- MR (whole body short tau inversion recovery (STIR)-sequence and T1-sequence and Diffusion weighted imaging (DWI),no contrast administration
- Validation of whole body diffusion weighted imaging in detection of bone metastases and visceral metastases, comparing to Bone scan en PET/CT results.
- To calculate cut-off values for DWI for bone and visceral metastases.
Second step : therapy follow-up/therapy assessment.
Two groups of patients (oncologist takes the decision about therapy)
- Patients treated by chemotherapy
- Patients treated by hormonal therapy
- on week 3, 12-16 and 52 in the chemotherapy or hormonal therapy-setting, a whole body MR (same protocol, no contrast) will be performed.
Whole body MR with DWI is useful and reliable to assess the treatment response.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01291082
|Contact: Steven Pansfirstname.lastname@example.org|
|University Hospitals Leuven||Recruiting|
|Leuven, Belgium, 3000|
|Contact: Steven Pans, MD 003216340505 email@example.com|
|Principal Investigator: Steven Pans, MD|
|Principal Investigator:||Steven Pans, MD||UZ Leuven Dept Radiology|