MRI to Detect Breast Tumors in Women

Breast Cancer Clinical Trial

Official title:

Breast MRI Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003302
• Other study ID #: CDR0000066242
• Secondary ID: UPCC-ACR-6883
• Status: Completed
• Phase: N/A
• Start date: May 1998
• Est. completion date: June 30, 2000

Study information

• Verified date: September 2019
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: June 30, 2000
• Est. primary completion date: June 30, 2000
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• biopsy

Diagnostic Test:
• magnetic resonance imaging

• mammography

Locations

Country	Name	City	State
Canada	University of Toronto	Toronto	Ontario
Germany	Universitaetskliniken Bonn	Bonn
Germany	Martin Luther Universitaet	Halle Saale
United States	Johns Hopkins Oncology Center	Baltimore	Maryland
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina
United States	Cancer Center at the University of Virginia	Charlottesville	Virginia
United States	Simmons Cancer Center - Dallas	Dallas	Texas
United States	University of Colorado Cancer Center	Denver	Colorado
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California
United States	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania
United States	UCSF Cancer Center and Cancer Research Institute	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada,  Germany, 

References & Publications (3)

Bluemke DA, Gatsonis CA, Chen MH, DeAngelis GA, DeBruhl N, Harms S, Heywang-Köbrunner 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 bi — View Citation

Schnall MD, Blume J, Bluemke DA, Deangelis GA, Debruhl N, Harms S, Heywang-Köbrunner 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 — View Citation

Schnall MD, Blume J, Bluemke DA, DeAngelis GA, DeBruhl N, Harms S, Heywang-Köbrunner 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 br — View Citation