MRI in Predicting Early Response to Chemotherapy in Patients With Locally Advanced Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00978770
Recruitment Status : Completed
First Posted : September 17, 2009
Last Update Posted : August 7, 2013
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: systemic chemotherapy Procedure: diffusion-weighted magnetic resonance imaging Procedure: dynamic contrast-enhanced magnetic resonance imaging Procedure: magnetic resonance spectroscopic imaging Procedure: neoadjuvant therapy Phase 2

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Primary Purpose: Diagnostic
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 Start Date : August 2009
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Primary Outcome Measures :
  1. 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
  2. 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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00978770

United Kingdom
Cactus Clinical Trials Unit
Hull, England, United Kingdom, HU3 2KZ
Sponsors and Collaborators
Cancer Clinical Trials Unit, Scotland
Principal Investigator: Lindsay W. Turnbull, MD Hull Royal Infirmary Identifier: NCT00978770     History of Changes
Other Study ID Numbers: CCTU-Neo-COMICE
CDR0000649054 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: September 17, 2009    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: September 2009

Keywords provided by National Cancer Institute (NCI):
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases