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

NCT ID: NCT00978770

Last Updated: 2013-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2010-01-31

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.

Conditions

Breast Cancer

Study Design

• Primary Study Purpose: DIAGNOSTIC

Interventions

systemic chemotherapy

Intervention Type: DRUG

diffusion-weighted magnetic resonance imaging

Intervention Type: PROCEDURE

dynamic contrast-enhanced magnetic resonance imaging

Intervention Type: PROCEDURE

magnetic resonance spectroscopic imaging

Intervention Type: PROCEDURE

neoadjuvant therapy

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cancer Clinical Trials Unit, Scotland

OTHER

Sponsor Role: lead

Principal Investigators

Lindsay W. Turnbull, MD

Role: PRINCIPAL_INVESTIGATOR

Hull Royal Infirmary

Locations

Cactus Clinical Trials Unit

Hull, England, United Kingdom

Countries

United Kingdom

Other Identifiers

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