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


N/A
18 Years
N/A
Not Enrolling
Both
Breast Cancer

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Trial Information

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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Retrospective

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.

Outcome 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.

Safety Issue:

Yes

Principal Investigator

Laura Liberman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

06-146

NCT ID:

NCT00580086

Start Date:

November 2006

Completion Date:

December 2009

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • MR spectroscopy
  • Neoadjuvant chemotherapy
  • Breast Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer Center New York, New York  10021