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

• Sponsor: University of North Carolina, Chapel Hill (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00630292
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arm: 1
• Duration (Months): 21
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Other: Magnetic Resonance Angiography (MRA) of the Breast	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Feasibility Study of Vessel Analysis for Noninvasive Diagnosis of Malignancy in Breast Tumors
• Study Start Date: Mar 1, 2008
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	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.

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UNC Hospitals	Chapel Hill	North Carolina	United States	27514

Sponsors and Collaborators

• University of North Carolina, Chapel Hill

Investigators

• Principal Investigator: William Irvin, MD, UNC-CH

Study Documents (Full-Text)

None provided.

More Information

Publications

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

• ClinicalTrials.gov Identifier: NCT00630292
• Other Study ID Numbers: LCCC0718
• First Posted: Mar 7, 2008
• Last Update Posted: May 18, 2010
• Last Verified: May 1, 2010

• Additional relevant MeSH terms: Breast Neoplasms

Study Results

Participant Flow

Arm/Group Title	Breast Magnetic Resonance Angiography
Arm/Group Description	Women who had a Magnetic Resonance Angiography sequence added to a clinical breast MRI
Period Title: Overall Study
STARTED	6
COMPLETED	5
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Breast Magnetic Resonance Angiography
Arm/Group Description	Women who had a Magnetic Resonance Angiography sequence added to a clinical breast MRI
Overall Participants	6
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	5 83.3%
>=65 years	1 16.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45.5 (5.49)
Sex: Female, Male (Count of Participants)
Female	6 100%
Male	0 0%
Region of Enrollment (participants) [Number]
United States	6 100%

Outcome Measures

1. Primary Outcome

Title	Amount of Blood Vessel Tortuosity in Breast With Known Cancer
Description	Amount of vessel tortuosity before the start of neoadjuvant chemotherapy and at the end of neoadjuvant chemotherapy
Time Frame	up to two weeks prior to start of chemotheraphy

Outcome Measure Data

Analysis Population Description

Blood vessels could not be detected for any of the subjects due to spatial resolution limits of MRI scanner for breast MRI and therefore measurement of blood vessel angularity could not be performed.

Arm/Group Title	Breast Magnetic Resonance Angiography
Arm/Group Description	Women who had a Magnetic Resonance Angiography sequence added to a clinical breast MRI
Measure Participants	0

Adverse Events

Adverse Event Reporting Description	No adverse events were observed.
Arm/Group Title	Breast Magnetic Resonance Angiography
Arm/Group Description	Women who had a Magnetic Resonance Angiography sequence added to a clinical breast MRI
All Cause Mortality
	Breast Magnetic Resonance Angiography
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Breast Magnetic Resonance Angiography
	Affected / at Risk (%)	# Events
Total	0/5 (0%)
Other (Not Including Serious) Adverse Events
	Breast Magnetic Resonance Angiography
	Affected / at Risk (%)	# Events
Total	0/5 (0%)

Limitations/Caveats

The software used to perform breast vessel analysis failed to detect any vessels in the breast due to the limited spatial resolution possible for breast imaging with the 1.5T Magnetic Resonance Imaging System used in the study.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.