Clinical trial NCT00003302: MRI to Detect Breast Tumors in Women
Official title: Breast MRI Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-03-01
Enrollment: 1500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: DIAGNOSTIC

Brief summary: RATIONALE: New imaging procedures, such as MRI, may improve the ability to detect breast tumors.

PURPOSE: Diagnostic study to determine the value of MRI in detecting breast tumors in women who have had suspicious mammographic or clinical examinations.

Detailed description: OBJECTIVES: I. Evaluate the performance of breast magnetic resonance imaging (MRI) in conjunction with mammography for the detection and characterization of lesions in women with suspicious mammographic or clinical examinations. II. Assess the incremental value of breast MRI to determine the local extent of cancer in these patients. III. Assess the value of breast MRI to determine the prevalence and characteristics of incidental enhancing lesions in the remainder of the breast.

OUTLINE: This is a multicenter study. Patients undergo a high resolution 3D post contrast magnetic resonance imaging (MRI) scan. Patients with enhancing abnormalities undergo a dynamic scan no less than 18 hours later. Some patients may require a third scan if a core biopsy is to be performed. Patients who are ultimately found to have cancer are assessed for extent of cancer including measurement of the index lesion and identification of other present foci of cancer in relation to the index lesion. Further histological diagnosis of index lesions is determined by MRI-guided needle localization excisional biopsy. Patients with benign needle biopsy are followed for 2 years. Patients with benign primary lesions receive a follow up MRI scan 1 year after the initial scan. Patients with benign primary lesions and incidental enhancing lesions (IEL) are followed at 2 years. Patients with negative needle biopsies not yielding a specific diagnosis and who do not undergo subsequent excisional biopsy are followed yearly for 2 years.

PROJECTED ACCRUAL: A total of 1500 patients will be accrued for this study over 4.25 years.

Eligibility criteria: DISEASE CHARACTERISTICS: Suspicious mammographic finding or palpable abnormality OR Suspicious clinical or ultrasound finding without associated benign mammographic features May have more than one suspicious lesion based on mammography or clinical exam if an index lesion is present Mammogram within 2 months prior to MRI scan and copy of films required of all patients 30 years of age and over Eligibility maintained if patient meets above criteria and has had: Breast implant Prior benign excisional or core biopsy at least 6 months prior to study Fine needle aspiration performed at any time Cancer in the contralateral breast No history of prior breast cancer in the study breast No benign excisional or core biopsy of the affected breast within the last 6 months

PATIENT CHARACTERISTICS: Age: 18 to 79 Sex: Women Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No implanted pacemaker Other: No implanted ferromagnetic device No ferromagnetic aneurysm clip No severe claustrophobia No ocular metal fragments No shrapnel injury No difficulty lying prone No poor venous access No impaired decision-making abilities Not pregnant

PRIOR CONCURRENT THERAPY: Not specified

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Los Angeles
country: United States
facility: Jonsson Comprehensive Cancer Center, UCLA
state: California
city: San Francisco
country: United States
facility: UCSF Cancer Center and Cancer Research Institute
state: California
city: Denver
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Baltimore
country: United States
facility: Johns Hopkins Oncology Center
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center, UNC
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania Cancer Center
state: Pennsylvania
city: Dallas
country: United States
facility: Simmons Cancer Center - Dallas
state: Texas
city: Houston
country: United States
facility: University of Texas - MD Anderson Cancer Center
state: Texas
city: Charlottesville
country: United States
facility: Cancer Center at the University of Virginia
state: Virginia
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
city: Bonn
country: Germany
facility: Universitaetskliniken Bonn
city: Halle Saale
country: Germany
facility: Martin Luther Universitaet
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Mitchell Schnall, PhD
role: STUDY_CHAIR
References:
citation: Schnall MD, Blume J, Bluemke DA, DeAngelis GA, DeBruhl N, Harms S, Heywang-Kobrunner SH, Hylton N, Kuhl CK, Pisano ED, Causer P, Schnitt SJ, Thickman D, Stelling CB, Weatherall PT, Lehman C, Gatsonis CA. Diagnostic architectural and dynamic features at breast MR imaging: multicenter study. Radiology. 2006 Jan;238(1):42-53. doi: 10.1148/radiol.2381042117.
citation: Schnall MD, Blume J, Bluemke DA, Deangelis GA, Debruhl N, Harms S, Heywang-Kobrunner SH, Hylton N, Kuhl CK, Pisano ED, Causer P, Schnitt SJ, Smazal SF, Stelling CB, Lehman C, Weatherall PT, Gatsonis CA. MRI detection of distinct incidental cancer in women with primary breast cancer studied in IBMC 6883. J Surg Oncol. 2005 Oct 1;92(1):32-8. doi: 10.1002/jso.20381.
citation: Bluemke DA, Gatsonis CA, Chen MH, DeAngelis GA, DeBruhl N, Harms S, Heywang-Kobrunner SH, Hylton N, Kuhl CK, Lehman C, Pisano ED, Causer P, Schnitt SJ, Smazal SF, Stelling CB, Weatherall PT, Schnall MD. Magnetic resonance imaging of the breast prior to biopsy. JAMA. 2004 Dec 8;292(22):2735-42. doi: 10.1001/jama.292.22.2735.