Expired Study
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Chapel Hill, North Carolina 27514


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.


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


Study is Available At:


Original ID:

LCCC0718


NCT ID:

NCT00630292


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Terminated


Study Phase:

N/A


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of North Carolina, Chapel Hill


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

Existing vessel analysis software could not


Study Type:

Interventional


Study Design:

Endpoint Classification: Efficacy Study, Interven


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

6


Enrollment Type:

Actual


Overall Contact Information

Official Name:William Irvin, MD
Principal Investigator
UNC-CH

Study Dates

Start Date:March 2008
Completion Date:December 2009
Completion Type:Actual
Primary Completion Date:December 2008
Primary Completion Type:Actual
Verification Date:May 2010
Last Changed Date:May 10, 2010
First Received Date:February 28, 2008
First Results Date:February 3, 2010

Study Outcomes

Outcome Type:Primary Outcome
Measure:Amount of Blood Vessel Tortuosity in Breast With Known Cancer
Time Frame:up to two weeks prior to start of chemotheraphy
Safety Issues:False
Description:Amount of vessel tortuosity before the start of neoadjuvant chemotherapy and at the end of neoadjuvant chemotherapy

Study Interventions

Intervention Type:Other
Name:Magnetic Resonance Angiography (MRA) of the Breast
Description: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.
Arm Name:1

Study Arms

Study Arm Type:Experimental
Arm Name:1

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of North Carolina, Chapel Hill

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation: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
Reference Type:Reference
Citation: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.
PMID:16179200
Reference Type:Reference
Citation: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.
PMID:17512217
Reference Type:Reference
Citation:McDonald DM, Baluk P. Significance of blood vessel leakiness in cancer. Cancer Res. 2002 Sep 15;62(18):5381-5.
PMID:12235011
Reference Type:Reference
Citation: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.
PMID:17709827
Reference Type:Reference
Citation: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.
PMID:15282350
Reference Type:Reference
Citation: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.
PMID:16169887

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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