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

Breast Cancer Clinical Trial

— METAMARBO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01291082
• Other study ID #: S53057
• Status: Recruiting
• Phase: N/A
• First received: February 3, 2011
• Last updated: January 26, 2013
• Start date: February 2011
• Est. completion date: August 2013

Study information

• Verified date: January 2013
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Steven Pans
• Phone: 003216340505
• Email: steven.pans[@]uzleuven.be
• Is FDA regulated: No
• Health authority: Belgium : Institutional Review Board, Local Medical and Ethical Committee.
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validation of whole body diffusion weighted MRI in breastcancer patients	whole body MRI will be correlated to the nucleair bone scan and PET-CT	6 months	No
Secondary	Whole body MRI with diffusion weighted imaging is a reliable imaging tool for therapy assessment		12 months	No