Monitoring Response to Neoadjuvant Chemotherapy by the Use of Breast Proton MR Spectroscopy
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.
Observational
Observational Model: Case-Only, Time Perspective: Retrospective
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 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.
Yes
Laura Liberman, MD
Principal Investigator
Memorial Sloan-Kettering Cancer Center
United States: Institutional Review Board
06-146
NCT00580086
November 2006
December 2009
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |