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:
Universitaire Ziekenhuizen Leuven
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
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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