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

NCT00580086 | Completed DMC

• 1 other identifier: 06-146
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast cancer; MR spectroscopy; Neoadjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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 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.

Study Arms (1)

1

Other: MR spectroscopy

Interventions

MR spectroscopy OTHER

(1H MRS) on 1.5 Tesla (1.5T), using a software package from General Electric Medical Systems, Milwaukee, WI

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Laura Liberman, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 24, 2007
• Study Start: November 1, 2006
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: December 24, 2009

Record last verified: 2009-12

Locations

US (1)