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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
History of Changes

February 28, 2008
May 10, 2010
March 2008
December 2008   (final data collection date for primary outcome measure)
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
To determine if vessel analysis obtained through non-invasive imaging can be used to detect breast cancer [ Time Frame: Prior to start of neoadjuvant chemotherapy and at the End of neoadjuvant chemotherapy but prior to surgery ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00630292 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Feasibility Study of Vessel Analysis for Noninvasive Diagnosis of Malignancy in Breast Tumors
Feasibility Study of Vessel Analysis for Noninvasive Diagnosis of Malignancy in Breast Tumors

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.
Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Breast Cancer
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.
Experimental: 1
Intervention: Other: Magnetic Resonance Angiography (MRA) of the Breast

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
6
December 2009
December 2008   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00630292
LCCC0718
No
Lisa Carey/ Principal Investigator, University of North Carolina-Chapel Hill
University of North Carolina, Chapel Hill
Not Provided
Principal Investigator: William Irvin, MD UNC-CH
University of North Carolina, Chapel Hill
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP