Feasibility Study of Vessel Analysis for Noninvasive Diagnosis of Malignancy in Breast Tumors
May 10, 2010 updated by: University of North Carolina, Chapel Hill
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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North Carolina
-
Chapel Hill, North Carolina, United States, 27514
- UNC Hospitals
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Amount of Blood Vessel Tortuosity in Breast With Known Cancer
Time Frame: up to two weeks prior to start of chemotheraphy
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: William Irvin, MD, UNC-CH
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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. doi: 10.1056/NEJMoa052911. Epub 2005 Sep 16. Erratum In: N Engl J Med. 2006 Oct 26;355(17):1840.
- 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.
- 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.
- 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(Suppl 1):S116-9. doi: 10.1016/j.neuroimage.2007.03.067. Epub 2007 Apr 25.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
February 28, 2008
First Submitted That Met QC Criteria
March 6, 2008
First Posted (Estimate)
March 7, 2008
Study Record Updates
Last Update Posted (Estimate)
May 18, 2010
Last Update Submitted That Met QC Criteria
May 10, 2010
Last Verified
May 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LCCC0718
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.