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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01291082

Acronym

METAMARBO

Enrollment

Registered

2011-02-07

Start date

2011-02-28

Completion date

2013-08-31

Last updated

2013-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast cancer, metastasis, bone, diffusion MRI

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Belgium

Contacts

Primary ContactSteven Pans

steven.pans@uzleuven.be003216340505

Outcome results