NCT01291082

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 7, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

January 29, 2013

Status Verified

January 1, 2013

Enrollment Period

2.2 years

First QC Date

February 3, 2011

Last Update Submit

January 26, 2013

Conditions

Breast Cancer

Keywords

Breast cancermetastasisbonediffusion MRI

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Whole body MRI with diffusion weighted imaging is a reliable imaging tool for therapy assessment

    12 months

Study Arms (1)

Breast cancer patients

Breast cancer patients

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Breast cancer patients

You may qualify if:

  • Patients with a proven breast cancer (by biopsy or imaging)
  • Bone metastases proven by MR, PET-CT or Bone. Patients with visceral metastases can be included if bone metastases are also present.
  • Patient with an informed consent.

You may not qualify if:

  • Patients with a single bone metastasis treated by Radiotherapy will be excluded.
  • Patients with contra-indication for MRI: pacemaker, cochlear implant, non MR compatible devices (Baclofenpump).
  • Claustrophobia
  • Patient in a bad general condition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Leuven

Leuven, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Steven Pans, MD

    UZ Leuven Dept Radiology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven Pans

CONTACT

003216340505steven.pans@uzleuven.be

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor radiologist

Study Record Dates

First Submitted

February 3, 2011

First Posted

February 7, 2011

Study Start

February 1, 2011

Primary Completion

April 1, 2013

Study Completion

August 1, 2013

Last Updated

January 29, 2013

Record last verified: 2013-01

Locations

BE(1)