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Breast MRI Protocol


N/A
18 Years
79 Years
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Breast MRI Protocol


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.

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

PRIOR CONCURRENT THERAPY: Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Diagnostic

Principal Investigator

Mitchell Schnall, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania

Authority:

United States: Federal Government

Study ID:

CDR0000066242

NCT ID:

NCT00003302

Start Date:

May 1998

Completion Date:

Related Keywords:

  • Breast Cancer
  • breast cancer
  • Breast Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
University of Colorado Cancer CenterDenver, Colorado  80262
Johns Hopkins Oncology CenterBaltimore, Maryland  21287
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Simmons Cancer Center - DallasDallas, Texas  75235-9154
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Cancer Center at the University of VirginiaCharlottesville, Virginia  22908
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205