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

• Conditions: Breast Cancer

• Registration Number: NCT01291082
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-03
• Study First Submitted QC: 2011-02-04
• Study First Posted: 2011-02-07
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-26
• Last Update Posted: 2013-01-29
• Primary Completion: 2013-04
• Study Completion: 2013-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Validation of whole body diffusion weighted MRI in breastcancer patients	6 months	whole body MRI will be correlated to the nucleair bone scan and PET-CT

Secondary Outcome Measures

Name	Time	Method
Whole body MRI with diffusion weighted imaging is a reliable imaging tool for therapy assessment	12 months

Trial Locations

Locations (1)

University Hospitals Leuven; 🇧🇪 Leuven, Belgium