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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-11-30

Study Completion Date

2015-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Tumors

Keywords

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breast diagnostic radiology suspicious breast tumors MRI

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Subjects with suspicious breast lesions that warrant further evaluation will be followed to determination and confirmation of diagnosis.

No interventions assigned to this group

2

Normal subjects used to evaluate software and to develop and optimize MR sequences will be examined.

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Andrzej Krol

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrzej Krol, PhD

Role: PRINCIPAL_INVESTIGATOR

State University of New York - Upstate Medical University

Locations

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SUNY Upstate Medical University

Syracuse, New York, United States

Site Status

Countries

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United States

Other Identifiers

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SUNYUMU 4909

Identifier Type: -

Identifier Source: org_study_id