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

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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

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

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:

Pisano ED, Gatsonis C, Hendrick E, Yaffe M, Baum JK, Acharyya S, Conant EF, Fajardo LL, Bassett L, D'Orsi C, Jong R, Rebner M; Digital Mammographic Imaging Screening Trial (DMIST) Investigators Group. Diagnostic performance of digital versus film mammography for breast-cancer screening. N Engl J Med. 2005 Oct 27;353(17):1773-83. Epub 2005 Sep 16.

Kriege M, Brekelmans CT, Boetes C, Besnard PE, Zonderland HM, Obdeijn IM, Manoliu RA, Kok T, Peterse H, Tilanus-Linthorst MM, Muller SH, Meijer S, Oosterwijk JC, Beex LV, Tollenaar RA, de Koning HJ, Rutgers EJ, Klijn JG; Magnetic Resonance Imaging Screening Study Group. Efficacy of MRI and mammography for breast-cancer screening in women with a familial or genetic predisposition. N Engl J Med. 2004 Jul 29;351(5):427-37.

Thukral A, Thomasson DM, Chow CK, Eulate R, Wedam SB, Gupta SN, Wise BJ, Steinberg SM, Liewehr DJ, Choyke PL, Swain SM. Inflammatory breast cancer: dynamic contrast-enhanced MR in patients receiving bevacizumab--initial experience. Radiology. 2007 Sep;244(3):727-35.

McDonald DM, Baluk P. Significance of blood vessel leakiness in cancer. Cancer Res. 2002 Sep 15;62(18):5381-5.

Bullitt E, Reardon DA, Smith JK. A review of micro- and macrovascular analyses in the assessment of tumor-associated vasculature as visualized by MR. Neuroimage. 2007;37 Suppl 1:S116-9. Epub 2007 Apr 25. Review.

Bullitt E, Zeng D, Gerig G, Aylward S, Joshi S, Smith JK, Lin W, Ewend MG. Vessel tortuosity and brain tumor malignancy: a blinded study. Acad Radiol. 2005 Oct;12(10):1232-40.

Bullitt E, Wolthusen PA, Brubaker L, Lin W, Zeng D, Van Dyke T. Malignancy-associated vessel tortuosity: a computer-assisted, MR angiographic study of choroid plexus carcinoma in genetically engineered mice. AJNR Am J Neuroradiol. 2006 Mar;27(3):612-9.

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 May 23, 2013

To Top