Expired Study
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Syracuse, New York 13210


Purpose:

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 summary:

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.


Criteria:

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 is Available At:


Original ID:

SUNYUMU 4909


NCT ID:

NCT00639171


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

Clinical Implementation and Evaluation of MR Spectroscopy for Breast Cancer Detection


Overall Status:

Completed


Study Phase:

N/A


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

70 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

State University of New York - Upstate Medical University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

2


Total Enrollment:

13


Enrollment Type:

Actual


Overall Contact Information

Official Name:Andrzej Krol, PhD
Principal Investigator
State University of New York - Upstate Medical University

Study Dates

Start Date:November 2005
Completion Date:August 2015
Completion Type:Actual
Primary Completion Date:August 2015
Primary Completion Type:Actual
Verification Date:October 2017
Last Changed Date:October 10, 2017
First Received Date:March 12, 2008

Study Outcomes

There are no available Study Outcomes

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:1
Description:Subjects with suspicious breast lesions that warrant further evaluation will be followed to determination and confirmation of diagnosis.
Study Arm Type:Other
Arm Name:2
Description:Normal subjects used to evaluate software and to develop and optimize MR sequences will be examined.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:State University of New York - Upstate Medical University

Samples and Retentions

Study Population: Subjects will be recruited from two ongoing clinical studies of the breast at SUNY Upstate Medical University.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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