Diffusion Weighted Magnetic Resonance Imaging of the Breast During Chemotherapy: Response Evaluation

This study is currently recruiting participants.
Verified September 2012 by Universitaire Ziekenhuizen Leuven
Sponsor:
Information provided by (Responsible Party):
Chantal Van Ongeval, MD, Phd, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01684735
First received: May 14, 2012
Last updated: September 12, 2012
Last verified: September 2012
  Purpose

Evaluation of the response to chemotherapy in breast cancer patients by the use of Diffusion-weighted magnetic resonance imaging of the breast before the start of chemotherapy, after one and 3 cycles of therapy and at the end of the therapy.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diffusion Weighted Magnetic Resonance Imaging of the Breast During Chemotherapy: Response Evaluation

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • Response to chemotherapy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    outcome is the results of pathology after chemotherapy and surgery. Data will be collected for a period of 1 year.


Estimated Enrollment: 30
Study Start Date: March 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
women with breast cancer and chemotherapy
women recently diagnosed with breast cancer and selected to start with neo-adjuvant chemotherapy (6 cycles) before surgery/therapy

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

women diagnosed with breast cancer and treated with neo-adjuvant chemotherapy

Criteria

Inclusion Criteria:

  • core biopsy with diagnosis of breast cancer
  • start of neo-adjuvant chemotherapy

Exclusion Criteria:

  • magnetic resonance imaging incompatibility
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01684735

Contacts
Contact: Chantal Van Ongeval, MD,PhD (0)16343746 ext +32 chantal.vanongeval@uzleuven.be

Locations
Belgium
University Hospitals Leuven Recruiting
Leuven, Belgium, 300
Contact: Hilde Vandenhoutte, Phd     (0)16343636     hilde.vandenhoutte@uzleuven.be    
Principal Investigator: Chantal Van Ongeval, MD,Phd            
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Chantal Van Ongeval, MD, Phd Universitaire Ziekenhuizen Leuven
  More Information

No publications provided

Responsible Party: Chantal Van Ongeval, MD, Phd, MD,Phd, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01684735     History of Changes
Other Study ID Numbers: B322201213618
Study First Received: May 14, 2012
Last Updated: September 12, 2012
Health Authority: Belgium: Institutional Review Board

Keywords provided by Universitaire Ziekenhuizen Leuven:
diffusion-weighted magnetic resonance imaging

Additional relevant MeSH terms:
Body Weight
Breast Neoplasms
Signs and Symptoms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 19, 2013