Whole-body MR in Staging Bone and Soft Tissue Metastases in Breast Cancer Patients(MetaMaRBo)
NCT ID: NCT01291082
Last Updated: 2013-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
50 participants
OBSERVATIONAL
2011-02-28
2013-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Breast cancer patients
Breast cancer patients
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
2. Patients with contra-indication for MRI: pacemaker, cochlear implant, non MR compatible devices (Baclofenpump).
3. Claustrophobia
4. Patient in a bad general condition.
20 Years
80 Years
ALL
No
Sponsors
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Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Steven Pans
Medical Doctor radiologist
Principal Investigators
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Steven Pans, MD
Role: PRINCIPAL_INVESTIGATOR
UZ Leuven Dept Radiology
Locations
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University Hospitals Leuven
Leuven, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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S53057
Identifier Type: -
Identifier Source: org_study_id
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