MedDataX Logo

Monitoring Response to Neoadjuvant Chemotherapy by the Use of Breast Proton MR Spectroscopy

NCT ID: NCT00580086

Last Updated: 2009-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-11-30

Study Completion Date

2009-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is being done to evaluate if MR spectroscopy will give us more information about whether or not your chemotherapy will work for you. Spectroscopy is a special set of pictures taken with Magnetic Resonance Imaging (MRI) that gives us information about the chemical composition of your breast cancer.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study aim is to perform MR Spectroscopy (1H MRS) on 1.5 Tesla (1.5T), using a software package from General Electric Medical Systems, Milwaukee, WI on 115 patients with biopsy proven adenocarcinoma of the breast, who will be receiving neoadjuvant chemotherapy as per standard therapeutic protocol, prior to surgical management. The spectroscopic data will be analyzed to determine whether this can enable early prediction of therapeutic response as assessed by RECIST and ultimately surgical pathology after the completion of the full course of drug treatment. The 1H MRS, which is performed at baseline, prior to treatment, halfway through and at the end of the chemotherapy course, just prior to surgery, will be added to the routine MRI examination for the affected breast. Since chemotherapy courses vary in length, the exact timeline will depend on the specific course given. 1H MRS will add 10 minutes to the routine MRI examination, but will not involve additional injections of contrast. In addition, we will perform two extra MRIs combined with 1H MRS examinations for the affected breast, one set the day after and the second set one week after the initiation of chemotherapy. The MRI and 1H MRS will be performed at Memorial Sloan-Kettering Cancer Center, 1275 York Avenue, NY, NY 10021 or at any offsite of MSKCC.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Breast cancer MR spectroscopy Neoadjuvant chemotherapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

MR spectroscopy

Intervention Type OTHER

(1H MRS) on 1.5 Tesla (1.5T), using a software package from General Electric Medical Systems, Milwaukee, WI

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MR spectroscopy

(1H MRS) on 1.5 Tesla (1.5T), using a software package from General Electric Medical Systems, Milwaukee, WI

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients need to be ≥ 18 years of age
* Patients with biopsy confirmed adenocarcinoma of the breast, scheduled to receive neoadjuvant chemotherapy prior to surgical management.

Exclusion Criteria

* Patients who would normally be excluded from undergoing an MRI examination include:

* Patients with a pacemaker, aneurysm clip or any other condition that would warrant avoidance of a strong magnetic field
* Patients who are pregnant
* Patients who are unable to comply or complete the MRI exam such as patients with claustrophobia and patients who have electrically, magnetically, or mechanically activated implants, such as heart pacemakers, certain types of artificial joints, inner ear implants, eye implants, or certain surgical clips used in vascular surgery.
* Patients who are not candidates for neoadjuvant chemotherapy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Memorial Sloan-Kettering Cancer Center

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Laura Liberman, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

http://www.mskcc.org

Memorial Sloan-Kettering Cancer Center

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

06-146

Identifier Type: -

Identifier Source: org_study_id