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


N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer

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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 HospitalsChapel Hill, North Carolina  27514