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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00639171
First Posted: March 20, 2008
Last Update Posted: October 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Andrzej Krol, State University of New York - Upstate Medical University
  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.

Condition
Breast Tumors

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical Implementation and Evaluation of MR Spectroscopy for Breast Cancer Detection

Resource links provided by NLM:


Further study details as provided by Andrzej Krol, State University of New York - Upstate Medical University:

Enrollment: 13
Study Start Date: November 2005
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.
  Eligibility

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
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.
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00639171


Locations
United States, New York
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
Sponsors and Collaborators
State University of New York - Upstate Medical University
Investigators
Principal Investigator: Andrzej Krol, PhD State University of New York - Upstate Medical University
  More Information

Responsible Party: Andrzej Krol, PhD, State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier: NCT00639171     History of Changes
Other Study ID Numbers: SUNYUMU 4909
First Submitted: March 12, 2008
First Posted: March 20, 2008
Last Update Posted: October 11, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Andrzej Krol, State University of New York - Upstate Medical University:
breast
diagnostic radiology
suspicious breast tumors
MRI

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases