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Completed

NCT Number: NCT00978770

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Cactus Clinical Trials Unit

Hull, England, HU3 2KZ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

systemic chemotherapy

Drug

diffusion-weighted magnetic resonance imaging

Procedure

Dynamic Contrast-Enhanced Magnetic Resonance Imaging

Procedure

magnetic resonance spectroscopic imaging

Procedure

neoadjuvant therapy

Procedure

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Cancer Clinical Trials Unit, Scotland

Other

Registry information

Official study 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

Important dates

Study start
2009
Study completion
2010
First posted
Sep 17, 2009
Registry last updated
Aug 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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