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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center.
ClinicalTrials.gov Identifier:
NCT00580086
First received: December 20, 2007
Last updated: December 23, 2009
Last verified: December 2009
History of Changes
  Purpose

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 Intervention
Breast Cancer
 Other: MR spectroscopy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Monitoring Response to Neoadjuvant Chemotherapy by the Use of Breast Proton MR Spectroscopy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Memorial Sloan Kettering Cancer Center.:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]
Enrollment: 19
Study Start Date: November 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 Other: MR spectroscopy
(1H MRS) on 1.5 Tesla (1.5T), using a software package from General Electric Medical Systems, Milwaukee, WI

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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

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

No publications provided

Responsible Party: Laura Liberman, MD, Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00580086     History of Changes
Other Study ID Numbers: 06-146
Study First Received: December 20, 2007
Last Updated: December 23, 2009
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on February 27, 2015