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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00474604 |
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Date of registration:
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16/05/2007 |
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Primary sponsor: |
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Public title:
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Breast MRI in Women With Known or Suspected Breast Cancer and in Healthy Participants
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Scientific title:
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MRI Evaluation of Breast Tumor Growth and Treatment Response |
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Date of first enrolment:
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March 2006 |
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Target sample size:
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200 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00474604 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Countries of recruitment
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United States
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Contacts
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Name:
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A. Bapsi Chakravarthy, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Vanderbilt-Ingram Cancer Center |
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Key inclusion & exclusion criteria
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DISEASE CHARACTERISTICS:
- Meets 1 of the following criteria:
- Healthy participant
- Patient with known or suspected breast disease
- Hormone receptor status unknown
PATIENT CHARACTERISTICS:
- Female
- Menopausal status not specified
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No patients who are acutely ill or deemed ineligible for study participation by their
treating physician
- No contraindication to MRI, including any of the following:
- Breast volume
- Obesity
- Foreign ferromagnetic materials in the body
PRIOR CONCURRENT THERAPY:
- No concurrent gadopentetate dimeglumine in patients or healthy participants with
known prior allergic reaction to the MRI contrast agent
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Cancer
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Intervention(s)
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Procedure: diffusion-weighted magnetic resonance imaging
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Procedure: dynamic contrast-enhanced magnetic resonance imaging
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Procedure: magnetic resonance spectroscopic imaging
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Primary Outcome(s)
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Correlation of biochemical data obtained from magnetic resonance analysis with clinical, radiological, and pathological findings
[Time Frame: At completion of treatment.]
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Establishment of an imaging data bank
[Time Frame: At completion of treatment.]
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Feasibility of using advanced, quantitative, multiparametric magnetic resonance imaging methods for characterizing breast tumors and predicting treatment response: correlate MRI findings with pathologic findings at time of definitive surgery.
[Time Frame: At completion of treatment.]
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Identification of surrogate biomarkers that can guide diagnosis and treatment of breast cancer
[Time Frame: At completion of treatment.]
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Secondary ID(s)
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BRE0588
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P30CA068485
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VU-VICC-BRE-0588
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VU-VICC-IRB-051230
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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