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Clinical Trials/NCT01291082
NCT01291082
Unknown
Not Applicable

Whole-body Magnetische Resonantie Voor Het Opsporen Van Bot- en Weke Delenmetastasen Bij patiënten Met Een Borstcarcinoom (MetaMaRBo)

Universitaire Ziekenhuizen KU Leuven1 site in 1 country50 target enrollmentFebruary 2011
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Universitaire Ziekenhuizen KU Leuven
Enrollment
50
Locations
1
Primary Endpoint
Validation of whole body diffusion weighted MRI in breastcancer patients
Last Updated
13 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
February 2011
End Date
August 2013
Last Updated
13 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Steven Pans

Medical Doctor radiologist

Universitaire Ziekenhuizen KU Leuven

Eligibility Criteria

Inclusion Criteria

  • Patients with a proven breast cancer (by biopsy or imaging)
  • Bone metastases proven by MR, PET-CT or Bone. Patients with visceral metastases can be included if bone metastases are also present.
  • Patient with an informed consent.

Exclusion Criteria

  • Patients with a single bone metastasis treated by Radiotherapy will be excluded.
  • Patients with contra-indication for MRI: pacemaker, cochlear implant, non MR compatible devices (Baclofenpump).
  • Claustrophobia
  • Patient in a bad general condition.

Outcomes

Primary Outcomes

Validation of whole body diffusion weighted MRI in breastcancer patients

Time Frame: 6 months

whole body MRI will be correlated to the nucleair bone scan and PET-CT

Secondary Outcomes

  • Whole body MRI with diffusion weighted imaging is a reliable imaging tool for therapy assessment(12 months)

Study Sites (1)

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