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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Universitaire Ziekenhuizen Leuven.
Recruitment status was  Recruiting
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on November 20, 2014