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

NCT00639171 | Completed

• 1 other identifier: SUNYUMU 4909
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Tumors

Keywords

breast; diagnostic radiology; suspicious breast tumors; MRI

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead

Study Sites (1)

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Andrzej Krol, PhD

  State University of New York - Upstate Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: March 12, 2008
• First Posted: March 20, 2008
• Study Start: November 1, 2005
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: December 14, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)