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

This study is currently recruiting participants. (see Contacts and Locations)
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 16, 2014