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

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ClinicalTrials.gov Identifier: NCT01291082
Recruitment Status : Unknown
Verified January 2013 by Steven Pans, Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Recruiting
First Posted : February 7, 2011
Last Update Posted : January 29, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Breast Cancer

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.


Study Design

Study Type : Observational
Estimated Enrollment : 50 participants
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)
Study Start Date : February 2011
Estimated Primary Completion Date : April 2013
Estimated Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Breast cancer patients
Breast cancer patients


Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Whole body MRI with diffusion weighted imaging is a reliable imaging tool for therapy assessment [ Time Frame: 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Steven Pans, Medical Doctor radiologist, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01291082     History of Changes
Other Study ID Numbers: S53057
First Posted: February 7, 2011    Key Record Dates
Last Update Posted: January 29, 2013
Last Verified: January 2013

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

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