Clinical trial NCT00630292: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2008-03-07
Enrollment: 6
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility 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

Primary outcomes:
measure: Amount of Blood Vessel Tortuosity in Breast With Known Cancer
timeFrame: up to two weeks prior to start of chemotheraphy
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Hospitals
state: North Carolina
Study officials:
affiliation: UNC-CH
name: William Irvin, MD
role: PRINCIPAL_INVESTIGATOR
References:
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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. doi: 10.1016/j.acra.2005.05.027.
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.