MRI to Detect Breast Tumors in Women

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2006 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003302
First received: November 1, 1999
Last updated: May 9, 2009
Last verified: February 2006

November 1, 1999
May 9, 2009
May 1998
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00003302 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
MRI to Detect Breast Tumors in Women
Breast MRI Protocol

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.

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.

Interventional
Not Provided
Primary Purpose: Diagnostic
Breast Cancer
  • Procedure: biopsy
  • Procedure: magnetic resonance imaging
  • Procedure: radiomammography
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1500
Not Provided
Not Provided

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 schrapnel injury No difficulty lying prone No poor venous access No impaired decision-making abilities Not pregnant

PRIOR CONCURRENT THERAPY: Not specified

Female
18 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Germany
 
NCT00003302
CDR0000066242, UPCC-ACR-6883
Not Provided
Not Provided
University of Pennsylvania
National Cancer Institute (NCI)
Study Chair: Mitchell Schnall, PhD Abramson Cancer Center of the University of Pennsylvania
National Cancer Institute (NCI)
February 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP