Whole-body Magnetische Resonantie Voor Het Opsporen Van Bot- en Weke Delenmetastasen Bij patiënten Met Een Borstcarcinoom (MetaMaRBo)
20 Years
80 Years
Both
Breast Cancer
Trial Information
Whole-body Magnetische Resonantie Voor Het Opsporen Van Bot- en Weke Delenmetastasen Bij patiënten Met Een Borstcarcinoom (MetaMaRBo)
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
Aim :
- 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)
1. Patients treated by chemotherapy
2. 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.
End-point:
Whole body MR with DWI is useful and reliable to assess the treatment response.
Inclusion Criteria:
1. Patients with a proven breast cancer (by biopsy or imaging)
2. Bone metastases proven by MR, PET-CT or Bone. Patients with visceral metastases can
be included if bone metastases are also present.
3. Patient with an informed consent.
Exclusion Criteria:
1. Patients with a single bone metastasis treated by Radiotherapy will be excluded.
2. Patients with contra-indication for MRI: pacemaker, cochlear implant, non MR
compatible devices (Baclofenpump).
3. Claustrophobia
4. Patient in a bad general condition.
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
Validation of whole body diffusion weighted MRI in breastcancer patients
Outcome Description:
whole body MRI will be correlated to the nucleair bone scan and PET-CT
Outcome Time Frame:
6 months
Safety Issue:
No
Principal Investigator
Steven Pans, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
UZ Leuven Dept Radiology
Authority:
Belgium : Institutional Review Board, Local Medical and Ethical Committee.
Study ID:
S53057
NCT ID:
NCT01291082
Start Date:
February 2011
Completion Date:
August 2013
Related Keywords:
- Breast Cancer
- Breast cancer
- metastasis
- bone
- diffusion MRI
- Breast Neoplasms
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