An observational study in Breast Cancer, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-12-24.
Sponsored by Memorial Sloan Kettering Cancer Center · Observational
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.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 19 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.
Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.
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Participants are asked to take part in this study because they have breast cancer and are scheduled to receive chemotherapy treatment before having surgery.
Exclusion Criteria:
Patients who would normally be excluded from undergoing an MRI examination include:
Other: MR spectroscopy
(1H MRS) on 1.5 Tesla (1.5T), using a software package from General Electric Medical Systems, Milwaukee, WI
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.
This study is completed, as verified in Dec 2009. You cannot join it, but the record below documents what was studied.
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Memorial Sloan Kettering Cancer Center