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

This study has been terminated.
(Existing vessel analysis software could not be applied to breast MRI data.)
Sponsor:
Information provided by:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00630292
First received: February 28, 2008
Last updated: May 10, 2010
Last verified: May 2010
  Purpose

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 Intervention
Breast Cancer
Other: Magnetic Resonance Angiography (MRA) of the Breast

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Feasibility Study of Vessel Analysis for Noninvasive Diagnosis of Malignancy in Breast Tumors

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Amount of Blood Vessel Tortuosity in Breast With Known Cancer [ Time Frame: up to two weeks prior to start of chemotheraphy ] [ Designated as safety issue: No ]
    Amount of vessel tortuosity before the start of neoadjuvant chemotherapy and at the end of neoadjuvant chemotherapy


Enrollment: 6
Study Start Date: March 2008
Study Completion Date: December 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: February 28, 2008
Results First Received: February 3, 2010
Last Updated: May 10, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 23, 2014