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

NCT ID: NCT00630292

Last Updated: 2010-05-18

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Magnetic Resonance Angiography (MRA) of the Breast

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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University of North Carolina-Chapel Hill

Principal Investigators

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William Irvin, MD

Role: PRINCIPAL_INVESTIGATOR

UNC-CH

Locations

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UNC Hospitals

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 16169887 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15282350 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17709827 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 12235011 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17512217 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16179200 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16552004 (View on PubMed)

Other Identifiers

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LCCC0718

Identifier Type: -

Identifier Source: org_study_id

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