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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00630292
• Other study ID #: LCCC0718
• Status: Terminated
• Phase: N/A
• First received: February 28, 2008
• Last updated: May 10, 2010
• Start date: March 2008
• Est. completion date: December 2009

Study information

• Verified date: May 2010
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: December 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Other:
• Magnetic Resonance Angiography (MRA) of the Breast
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.

Locations

Country	Name	City	State
United States	UNC Hospitals	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

References & Publications (7)

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:S116-9. Epub 2007 Apr 25. Review. — View 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. — View 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. — View Citation

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. — View Citation

McDonald DM, Baluk P. Significance of blood vessel leakiness in cancer. Cancer Res. 2002 Sep 15;62(18):5381-5. — View Citation

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. Epub 2005 Sep 16. Erratum in: N Engl J Med. 2006 Oct 26;355(17):1840. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of Blood Vessel Tortuosity in Breast With Known Cancer	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	No