Expired Study
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New York, New York 10065


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.


Study summary:

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.


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


Study is Available At:


Original ID:

06-146


NCT ID:

NCT00580086


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Memorial Sloan-Kettering Cancer Center


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Case-Only, Time Perspective:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

19


Enrollment Type:

Actual


Overall Contact Information

Official Name:Laura Liberman, MD
Principal Investigator
Memorial Sloan-Kettering Cancer Center

Study Dates

Start Date:November 2006
Completion Date:December 2009
Completion Type:Actual
Primary Completion Date:December 2009
Primary Completion Type:Actual
Verification Date:December 2009
Last Changed Date:December 23, 2009
First Received Date:December 20, 2007

Study Outcomes

Outcome Type:Primary Outcome
Measure: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 bef
Safety Issues:True

Study Interventions

Intervention Type:Other
Name:MR spectroscopy
Description:(1H MRS) on 1.5 Tesla (1.5T), using a software package from General Electric Medical Systems, Milwaukee, WI
Arm Name:1

Study Arms

Study Arm Type:Other
Arm Name:1

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Memorial Sloan-Kettering Cancer Center
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Samples and Retentions

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.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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