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

Not Applicable

Terminated

• Conditions: Breast Cancer

• Registration Number: NCT00630292
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-02-28
• Study Start: 2008-03
• Study First Submitted QC: 2008-03-06
• Study First Posted: 2008-03-07
• Primary Completion: 2008-12
• Study Completion: 2009-12
• Results First Submitted: 2010-02-03
• Results First Submitted QC: 2010-04-14
• Status Verified: 2010-05
• Results First Posted: 2010-05-05
• Last Update Submitted: 2010-05-10
• Last Update Posted: 2010-05-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Amount of Blood Vessel Tortuosity in Breast With Known Cancer	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

Trial Locations

Locations (1)

UNC Hospitals; 🇺🇸 Chapel Hill, North Carolina, United States