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

NCT ID: NCT01291082

Last Updated: 2013-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2013-08-31

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Breast cancer patients

Breast cancer patients

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Steven Pans

Medical Doctor radiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Steven Pans, MD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven Dept Radiology

Locations

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University Hospitals Leuven

Leuven, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Steven Pans

Role: CONTACT

003216340505

Facility Contacts

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Steven Pans, MD

Role: primary

003216340505

Other Identifiers

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S53057

Identifier Type: -

Identifier Source: org_study_id

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