NCT00003302

MRI to Detect Breast Tumors in Women

Breast MRI Protocol

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,500 (estimated)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: Female
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	biopsy
DIAGNOSTIC_TEST	magnetic resonance imaging
DIAGNOSTIC_TEST	mammography

Timeline

• Start date: 1998-05-01
• Primary completion: 2000-06-30
• Completion: 2000-06-30
• First posted: 2004-03-01
• Last updated: 2019-09-25

Locations

15 sites across 3 countries: United States, Canada, Germany