Neo Comice Pilot; Efficacy of Advanced Semi-automated Functional Magnetic Resonance (MR) Imaging in the Early Prediction of Response of Locally Advanced Breast Cancer to Neoadjuvant Chemotherapy
18 Years
N/A
Female
Breast Cancer
Trial Information
Neo Comice Pilot; Efficacy of Advanced Semi-automated Functional Magnetic Resonance (MR) Imaging in the Early Prediction of Response of Locally Advanced Breast Cancer to Neoadjuvant Chemotherapy
OBJECTIVES:
- 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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Diagnostic
Outcome Measure:
Failed scan rate (i.e., the number of scans that failed protocol) grouped by cause, including patient refusal, protocol violation in timing, major errors in scan protocols, and minor errors in scan protocol
Safety Issue:
No
Principal Investigator
Lindsay W. Turnbull, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Hull Royal Infirmary
Authority:
Unspecified
Study ID:
CDR0000649054
NCT ID:
NCT00978770
Start Date:
August 2009
Completion Date:
Related Keywords:
- Breast Cancer
- stage II breast cancer
- stage IIIA breast cancer
- stage IIIB breast cancer
- stage IIIC breast cancer
- Breast Neoplasms
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