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Whole-body MR in Staging Bone and Soft Tissue Metastases in Breast Cancer Patients(MetaMaRBo)
Conditions
Breast Cancer
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
Breast cancer, metastasis, bone, diffusion MRI
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Case-Only, Time Perspective: Prospective
Overall Status
Recruiting
Summary
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.
Detailed Description
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 20 Years
Gender: Both
Criteria: 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.
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.
Location
University Hospitals Leuven
Leuven, Belgium
Status: Recruiting
Contact: Steven Pans, MD - 003216340505 - steven.pans@uzleuven.be
Start Date
February 2011
Completion Date
August 2013
Sponsors
Universitaire Ziekenhuizen Leuven
Source
Universitaire Ziekenhuizen Leuven
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page