Monitoring Response to Neoadjuvant Chemotherapy by the Use of Breast Proton MR Spectroscopy
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | December 20, 2007 | ||||
| Last Updated Date | December 23, 2009 | ||||
| Start Date ICMJE | November 2006 | ||||
| Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00580086 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Monitoring Response to Neoadjuvant Chemotherapy by the Use of Breast Proton MR Spectroscopy | ||||
| Official Title ICMJE | Monitoring Response to Neoadjuvant Chemotherapy by the Use of Breast Proton MR Spectroscopy | ||||
| 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. |
||||
| 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 Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Retrospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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. |
||||
| Condition ICMJE | Breast Cancer | ||||
| Intervention ICMJE | Other: MR spectroscopy
(1H MRS) on 1.5 Tesla (1.5T), using a software package from General Electric Medical Systems, Milwaukee, WI |
||||
| Study Group/Cohort (s) | 1
Intervention: Other: MR spectroscopy |
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 19 | ||||
| Completion Date | December 2009 | ||||
| Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00580086 | ||||
| Other Study ID Numbers ICMJE | 06-146 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Laura Liberman, MD, Memorial Sloan-Kettering Cancer Center | ||||
| Study Sponsor ICMJE | Memorial Sloan-Kettering Cancer Center | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Memorial Sloan-Kettering Cancer Center | ||||
| Verification Date | December 2009 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||