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Trial Title:
Whole-body MR in Staging Bone and Soft Tissue Metastases in Breast Cancer Patients(MetaMaRBo)
NCT ID:
NCT01291082
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Breast cancer
metastasis
bone
diffusion MRI
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
Breast cancer patients
Sampling method:
Probability Sample
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.
Gender:
All
Minimum age:
20 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University Hospitals Leuven
Address:
City:
Leuven
Zip:
3000
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Steven Pans, MD
Phone:
003216340505
Email:
steven.pans@uzleuven.be
Investigator:
Last name:
Steven Pans, MD
Email:
Principal Investigator
Start date:
February 2011
Completion date:
August 2013
Lead sponsor:
Agency:
Universitaire Ziekenhuizen KU Leuven
Agency class:
Other
Source:
Universitaire Ziekenhuizen KU Leuven
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01291082
