MRI in Predicting Early Response to Chemotherapy in Patients With Locally Advanced Breast Cancer
Primary Purpose
Breast Cancer
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
systemic chemotherapy
diffusion-weighted magnetic resonance imaging
dynamic contrast-enhanced magnetic resonance imaging
magnetic resonance spectroscopic imaging
neoadjuvant therapy
Sponsored by

About this trial
This is an interventional diagnostic trial for Breast Cancer focused on measuring stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
Eligibility 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
Sites / Locations
- Cactus Clinical Trials Unit
Outcomes
Primary Outcome Measures
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
Failed automated MRI-scan data-analysis rate (i.e., number of scans that required manual reading and number of protocol-compliant scans that were unreadable, subdivided according to whether the scans were technically compliant or not)
Secondary Outcome Measures
Full Information
NCT ID
NCT00978770
First Posted
September 16, 2009
Last Updated
August 6, 2013
Sponsor
Cancer Clinical Trials Unit, Scotland
1. Study Identification
Unique Protocol Identification Number
NCT00978770
Brief Title
MRI in Predicting Early Response to Chemotherapy in Patients With Locally Advanced Breast Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Cancer Clinical Trials Unit, Scotland
4. Oversight
5. Study Description
Brief Summary
RATIONALE: Diagnostic procedures such as MRI scans may help predict early response to treatment in patients with breast cancer undergoing chemotherapy.
PURPOSE: This phase II trial is studying MRI in predicting early response to chemotherapy in patients with locally advanced breast cancer.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
systemic chemotherapy
Intervention Type
Procedure
Intervention Name(s)
diffusion-weighted magnetic resonance imaging
Intervention Type
Procedure
Intervention Name(s)
dynamic contrast-enhanced magnetic resonance imaging
Intervention Type
Procedure
Intervention Name(s)
magnetic resonance spectroscopic imaging
Intervention Type
Procedure
Intervention Name(s)
neoadjuvant therapy
Primary Outcome Measure Information:
Title
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
Title
Failed automated MRI-scan data-analysis rate (i.e., number of scans that required manual reading and number of protocol-compliant scans that were unreadable, subdivided according to whether the scans were technically compliant or not)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lindsay W. Turnbull, MD
Organizational Affiliation
Hull Royal Infirmary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cactus Clinical Trials Unit
City
Hull
State/Province
England
ZIP/Postal Code
HU3 2KZ
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
MRI in Predicting Early Response to Chemotherapy in Patients With Locally Advanced Breast Cancer
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