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

Universitaire Ziekenhuizen KU Leuven

Status: Unknown

Conditions: Breast Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT01291082

S53057

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No 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.

Trial design

50 participants in 1 patient group

Breast cancer patients

Description:

Breast cancer patients