Evaluate the Use of the Magnetic Resonance Spectroscopy in Determining if the Breast Tumor is Benign or Malignant

Clinical Implementation and Evaluation of MR Spectroscopy for Breast Cancer Detection

Magnetic Resonance Spectroscopy (MRS) is a novel imaging technique for noninvasive probing of biochemical properties of tissue. While MRS does not generate images of tumor per se it allows biochemical spectroscopic data to be obtained in vivo from user defined region-of-interest. In this manner, biochemical information elucidated by MRS can be interpreted in relation to detailed anatomy and images of metabolite distribution can be created. The aim of MRS is to identify presence and concentration of metabolites characteristic for normal and abnormal (tumor) cellular activities hence allow differential normal tissue from pathological tissue, as well as allow differentiating malignant from benign tumors.

Study Overview

• Status: Completed
• Conditions: Breast Tumors

Detailed Description

Recent in vivo studies have reported successful use of 1H and 31P MRS in differentiating between benign and malignant tumors in breast tissue. These studies demonstrated an increase in the choline metabolite peak that reflects an increase in choline-containing metabolites in 70-80% of breast carcinomas, as compared to 14-18% of benign breast tumors.The objectives would be to determine sensitivity/specificity of MRS in the context of breast CA, We will use normal volunteers to test software and to develop and optimize MR scan sequences prior to or during the testing of target subjects with suspicious breast lesion.

• Study Type: Observational
• Enrollment (Actual): 3

Contacts and Locations

Study Locations

• United States
  • New York
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from two ongoing clinical studies of the breast at SUNY Upstate Medical University.

Description

Inclusion Criteria:

• subjects should have well defined suspicious breast lesion and that will be biopsied
• subjects are to include; varied volunteers with different breast tissue with characteristics such as dense breasts, fibrocystic breasts, "small" breasted and "large" breasted women.

Exclusion Criteria:

• Women of childbearing potential who are not practicing a medically accepted method of birth control should not participate
• Subjects that are pregnant, breast-feeding, should not be able to participate
• Subjects having any of the following metallic devices, will be ineligible to participate in the study: pacemaker, prosthesis, artificial heart valve, coronary artery stents, TENS (Transcutaneous electric nerve stimulator) or other neurological stimulation units and surgical clips.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
1; Subjects with suspicious breast lesions that warrant further evaluation will be followed to determination and confirmation of diagnosis.
2; Normal subjects used to evaluate software and to develop and optimize MR sequences will be examined.

Collaborators and Investigators

• Sponsor: State University of New York - Upstate Medical University
• Investigators: Principal Investigator: Andrzej Krol, PhD, State University of New York - Upstate Medical University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2005
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: March 12, 2008
• First Submitted That Met QC Criteria: March 19, 2008
• First Posted (Estimated): March 20, 2008

Study Record Updates

• Last Update Posted (Estimated): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: MRI; breast; diagnostic radiology; suspicious breast tumors
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: SUNYUMU 4909

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No