Monitoring Response to Neoadjuvant Chemotherapy by the Use of Breast Proton MR Spectroscopy
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ClinicalTrials.gov Identifier: NCT00580086 |
Recruitment Status
:
Completed
First Posted
: December 24, 2007
Last Update Posted
: December 24, 2009
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Condition or disease | Intervention/treatment |
---|---|
Breast Cancer | Other: MR spectroscopy |
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 |

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
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- 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. ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

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
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10065 |
Principal Investigator: | Laura Liberman, MD | Memorial Sloan Kettering Cancer Center |
Additional Information:
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 |