MRI in Predicting Early Response to Chemotherapy in Patients With Locally Advanced Breast Cancer
NCT ID: NCT00978770
Last Updated: 2013-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2009-08-31
2010-01-31
Brief Summary
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PURPOSE: This phase II trial is studying MRI in predicting early response to chemotherapy in patients with locally advanced breast cancer.
Detailed Description
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* To determine the technical feasibility of using MRI in a multicenter setting using the most commonly available magnetic resonance (MR) systems (i.e., is the trial able to scan patients to a specific protocol, using different types of MRI machine) measured by the number of MRI scans not completed to technical specifications (i.e., incorrect sequences or incomplete scans) or trial protocol (i.e., scans not completed or completed at the wrong time).
* To determine how reliably the imaging data can be analyzed in a centralized, semi-automated manner (i.e., can MRI data be reliably transferred from different centers and analyzed using software based in the center for MR investigations at the University of Hull) measured by the number of cases where automated data analysis of completed MRI scans was not possible (i.e., data could not be analyzed at all or data required manual analysis).
OUTLINE: This is a multicenter study.
Patients undergo magnetic resonance imaging (MRI) scans at baseline, 4-7 days after beginning after the first course of chemotherapy, at the end of their second course of chemotherapy, and at the end of their fourth course of chemotherapy (first regimen). MRI techniques may include dynamic contrast-enhanced, diffusion-weighted, and spectroscopic.
Conditions
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Keywords
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Study Design
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DIAGNOSTIC
Interventions
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systemic chemotherapy
diffusion-weighted magnetic resonance imaging
dynamic contrast-enhanced magnetic resonance imaging
magnetic resonance spectroscopic imaging
neoadjuvant therapy
Eligibility Criteria
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Inclusion Criteria
* Newly diagnosed, histologically proven breast cancer
* Stage T2-4B, N0-3C, and M0 disease
* Locally advanced primary disease
* Underwent both x-ray mammography and breast ultrasound scanning during the current treatment episode
* Scheduled for neoadjuvant chemotherapy
PATIENT CHARACTERISTICS:
* Not pregnant or nursing
* Medically stable
* No renal failure
* No serious breast trauma within the past 3 months
* No known allergic reaction associated with previous administration of a paramagnetic contrast agent
* No known contraindication to magnetic resonance (MR) scanning
* Must pass the normal safety requirements of MR, particularly pacemakers and cardiac defibrillators
* No disability preventing MR scanning in the prone position
* No body habitus incompatible with MR system entry
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior chemotherapy
* No prior surgery or radiotherapy for cancer in the ipsilateral breast
* More than 4 months since prior surgery to the ipsilateral breast for benign breast disease
18 Years
FEMALE
No
Sponsors
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Cancer Clinical Trials Unit, Scotland
OTHER
Principal Investigators
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Lindsay W. Turnbull, MD
Role: PRINCIPAL_INVESTIGATOR
Hull Royal Infirmary
Locations
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Cactus Clinical Trials Unit
Hull, England, United Kingdom
Countries
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Other Identifiers
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CDR0000649054
Identifier Type: REGISTRY
Identifier Source: secondary_id
ISRCTN42613663
Identifier Type: -
Identifier Source: secondary_id
EU-20968
Identifier Type: -
Identifier Source: secondary_id
CCTU-Neo-COMICE
Identifier Type: -
Identifier Source: org_study_id