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

NCT00630292 | Terminated Results

• 1 other identifier: LCCC0718
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Amount of Blood Vessel Tortuosity in Breast With Known Cancer

  Amount of vessel tortuosity before the start of neoadjuvant chemotherapy and at the end of neoadjuvant chemotherapy

  up to two weeks prior to start of chemotheraphy

Study Arms (1)

1

EXPERIMENTAL

Other: Magnetic Resonance Angiography (MRA) of the Breast

Interventions

Magnetic Resonance Angiography (MRA) of the Breast OTHER

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.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

UNC Hospitals

Chapel Hill, North Carolina, 27514, United States

Location

Related Publications (7)

• 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. doi: 10.1056/NEJMoa052911. Epub 2005 Sep 16.

  PMID: 16169887 BACKGROUND

• 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. doi: 10.1056/NEJMoa031759.

  PMID: 15282350 BACKGROUND

• 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. doi: 10.1148/radiol.2443060926.

  PMID: 17709827 BACKGROUND

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

  PMID: 12235011 BACKGROUND

• 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(Suppl 1):S116-9. doi: 10.1016/j.neuroimage.2007.03.067. Epub 2007 Apr 25.

  PMID: 17512217 BACKGROUND

• 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. doi: 10.1016/j.acra.2005.05.027.

  PMID: 16179200 BACKGROUND

• 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.

  PMID: 16552004 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

The software used to perform breast vessel analysis failed to detect any vessels in the breast due to the limited spatial resolution possible for breast imaging with the 1.5T Magnetic Resonance Imaging System used in the study.

Results Point of Contact

• Title: William Irvin, Jr. MD / Co-Principal Investigator
• Organization: University of North Carolina

william_irvin@med.unc.edu

919-966-6735

Study Officials

• William Irvin, MD

  UNC-CH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 28, 2008
• First Posted: March 7, 2008
• Study Start: March 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2009
• Last Updated: May 18, 2010
• Results First Posted: May 5, 2010

Record last verified: 2010-05

Locations

US (1)