Trial Information
Feasibility Study of Vessel Analysis for Noninvasive Diagnosis of Malignancy in Breast Tumors
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Amount of Blood Vessel Tortuosity in Breast With Known Cancer
Outcome Description:
Amount of vessel tortuosity before the start of neoadjuvant chemotherapy and at the end of neoadjuvant chemotherapy
Outcome Time Frame:
up to two weeks prior to start of chemotheraphy
Safety Issue:
No
Principal Investigator
William Irvin, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
UNC-CH
Authority:
United States: Institutional Review Board
Study ID:
LCCC0718
NCT ID:
NCT00630292
Start Date:
March 2008
Completion Date:
December 2009
Related Keywords:
- Breast Cancer
- Breast Neoplasms
Name | Location |
UNC Hospitals |
Chapel Hill, North Carolina 27514 |