ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT00580086
Recruitment Status : Completed
First Posted : December 24, 2007
Last Update Posted : December 24, 2009
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment
Breast Cancer Other: MR spectroscopy

Detailed Description:
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.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Observational
Actual Enrollment : 19 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Monitoring Response to Neoadjuvant Chemotherapy by the Use of Breast Proton MR Spectroscopy
Study Start Date : November 2006
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
1 Other: MR spectroscopy
(1H MRS) on 1.5 Tesla (1.5T), using a software package from General Electric Medical Systems, Milwaukee, WI


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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. [ Time Frame: The 1st MRI before start chemotherapy, the 2nd MRI half way through treatment, and the final MRI before surgery. Two MRI exams will be for research only. ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants are asked to take part in this study because they have breast cancer and are scheduled to receive chemotherapy treatment before having surgery.
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): NCT00580086


Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Laura Liberman, MD Memorial Sloan Kettering Cancer Center
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Memorial Sloan-Kettering Cancer Center  This link exits the ClinicalTrials.gov site

Responsible Party: Laura Liberman, MD, Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00580086     History of Changes
Other Study ID Numbers: 06-146
First Posted: December 24, 2007    Key Record Dates
Last Update Posted: December 24, 2009
Last Verified: December 2009

Keywords provided by Memorial Sloan Kettering Cancer Center:
Breast cancer
MR spectroscopy
Neoadjuvant chemotherapy