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Feasibility Study of Vessel Analysis for Noninvasive Diagnosis of Malignancy in Breast Tumors

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.
ClinicalTrials.gov Identifier: NCT00630292
Recruitment Status : Terminated (Existing vessel analysis software could not be applied to breast MRI data.)
First Posted : March 7, 2008
Results First Posted : May 5, 2010
Last Update Posted : May 18, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
This is a pilot study designed to explore the feasibility of non-invasively diagnosing the presence of cancer in the breast using non-invasive magnetic resonance imaging (MRI) methods and an analysis of vessel shape defined from these magnetic resonance images.

Condition or disease Intervention/treatment
Breast Cancer Other: Magnetic Resonance Angiography (MRA) of the Breast

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Feasibility Study of Vessel Analysis for Noninvasive Diagnosis of Malignancy in Breast Tumors
Study Start Date : March 2008
Primary Completion Date : December 2008
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Other: Magnetic Resonance Angiography (MRA) of the Breast
Magnetic Resonance Angiography (MRA) of the breast will be performed before or after pre-treatment magnetic resonance imaging (MRI) and then once again before or after the post-treatment MRI.


Outcome Measures

Primary Outcome Measures :
  1. Amount of Blood Vessel Tortuosity in Breast With Known Cancer [ Time Frame: up to two weeks prior to start of chemotheraphy ]
    Amount of vessel tortuosity before the start of neoadjuvant chemotherapy and at the end of neoadjuvant chemotherapy


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult women (age >= 18),
  • with Histologically documented newly diagnosed stage II-IV invasive breast cancer appropriate for neoadjuvant (preoperative) systemic therapy.
  • ECOG performance status of 0, 1, or 2 at the initiation of the study.

Exclusion Criteria:

  • pregnant women
  • women with contralateral mastectomies
  • known bilateral tumors
  • subjects prone to claustrophobia
  • contraindicated to have MRI
  • mentally impaired
  • not fluent in english
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): NCT00630292


Locations
United States, North Carolina
UNC Hospitals
Chapel Hill, North Carolina, United States, 27514
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: William Irvin, MD UNC-CH
More Information

Publications:

Responsible Party: Lisa Carey/ Principal Investigator, University of North Carolina-Chapel Hill
ClinicalTrials.gov Identifier: NCT00630292     History of Changes
Other Study ID Numbers: LCCC0718
First Posted: March 7, 2008    Key Record Dates
Results First Posted: May 5, 2010
Last Update Posted: May 18, 2010
Last Verified: May 2010

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