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Whole-body MR in Staging Bone and Soft Tissue Metastases in Breast Cancer Patients(MetaMaRBo) (METAMARBO)

This study is currently recruiting participants.
Verified January 2013 by Universitaire Ziekenhuizen Leuven
Sponsor:
Information provided by (Responsible Party):
Steven Pans, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01291082
First received: February 3, 2011
Last updated: January 26, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Whole-body Magnetische Resonantie Voor Het Opsporen Van Bot- en Weke Delenmetastasen Bij patiënten Met Een Borstcarcinoom (MetaMaRBo)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • Validation of whole body diffusion weighted MRI in breastcancer patients [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    whole body MRI will be correlated to the nucleair bone scan and PET-CT


Secondary Outcome Measures:
  • Whole body MRI with diffusion weighted imaging is a reliable imaging tool for therapy assessment [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: February 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Breast cancer patients
Breast cancer patients

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Breast cancer patients

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01291082

Contacts
Contact: Steven Pans 003216340505 steven.pans@uzleuven.be

Locations
Belgium
University Hospitals Leuven Recruiting
Leuven, Belgium, 3000
Contact: Steven Pans, MD     003216340505     steven.pans@uzleuven.be    
Principal Investigator: Steven Pans, MD            
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Steven Pans, MD UZ Leuven Dept Radiology
  More Information

No publications provided

Responsible Party: Steven Pans, Medical Doctor radiologist, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01291082     History of Changes
Other Study ID Numbers: S53057
Study First Received: February 3, 2011
Last Updated: January 26, 2013
Health Authority: Belgium : Institutional Review Board, Local Medical and Ethical Committee.

Keywords provided by Universitaire Ziekenhuizen Leuven:
Breast cancer
metastasis
bone
diffusion MRI

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 21, 2013