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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00978770
First received: September 16, 2009
Last updated: August 6, 2013
Last verified: September 2009
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

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 [ Designated as safety issue: No ]
  • 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) [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: August 2009
Study Completion Date: January 2010
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00978770

Locations
United Kingdom
Cactus Clinical Trials Unit
Hull, England, United Kingdom, HU3 2KZ
Sponsors and Collaborators
Cactus Clinical Trials Unit
Investigators
Principal Investigator: Lindsay W. Turnbull, MD Hull Royal Infirmary
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00978770     History of Changes
Other Study ID Numbers: CCTU-Neo-COMICE, CDR0000649054, ISRCTN42613663, EU-20968
Study First Received: September 16, 2009
Last Updated: August 6, 2013
Health Authority: Unspecified

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
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 20, 2014