Magnetic Resonance Imaging in Women Recently Diagnosed With Unilateral Breast Cancer - Full Text View

Sponsor:	American College of Radiology Imaging Network
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00058058

Purpose

RATIONALE: Diagnostic procedures such as magnetic resonance imaging (MRI) may improve the ability to detect cancer in the unaffected breast of women recently diagnosed with unilateral breast cancer.

PURPOSE: Diagnostic trial to determine the effectiveness of MRI in evaluating the unaffected breast of women recently diagnosed with unilateral breast cancer.

Condition	Intervention
Breast Cancer	Procedure: magnetic resonance imaging Radiation: gadopentetate dimeglumine

Study Type:	Interventional
Study Design:	Diagnostic
Official Title:	MRI Evaluation Of The Contralateral Breast In Women With Recent Diagnosis Of Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer MRI Scans

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

February 2001

Detailed Description:

OBJECTIVES:

Determine the diagnostic yield of magnetic resonance imaging (MRI) in evaluating the contralateral breast of women with a recent unilateral diagnosis of breast cancer and a negative contralateral mammogram and clinical breast exam.
Determine the sensitivity, specificity, positive predictive value for both call backs for additional imaging and biopsy recommendations, and receiver operating characteristic curves of MRI in evaluating these patients.
Determine the effect of the following patient-related factors: age (50 years old and over vs less than 50 years old), breast parenchymal density (fatty vs non fatty breast), and tumor histology (invasive lobular vs invasive ductal, invasive vs in situ) on the performance of MRI (cancer yield, sensitivity, specificity, and PPV).

OUTLINE: This is a multicenter study.

Patients receive gadopentetate dimeglumine IV and then undergo magnetic resonance imaging of the contralateral breast.

Patients are followed at 12-18 and 24-30 months.

PROJECTED ACCRUAL: A total of 1,000 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Recently confirmed unilateral ductal carcinoma in situ or invasive cancer of the breast
- Confirmed by biopsy or fine needle aspiration (FNA) within the past 60 days
Negative or benign mammogram (BI-RADS assessment 1 or 2) and negative or benign clinical breast exam of the contralateral breast within the past 90 days
Prior biopsy of the contralateral breast (including FNA) is allowed provided it was performed at least 6 months prior to study entry
Prior magnetic resonance exam of the contralateral breast is allowed provided it was performed at least 1 year prior to study entry
No remote history of breast cancer
No new breast symptoms within the past 60 days for which further evaluation is recommended
Hormone receptor status:
- Not specified

PATIENT CHARACTERISTICS:

Age

18 and over

Sex

Female

Menopausal status

Not specified

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

Cardiovascular

No pacemaker
No magnetic aneurysm clips

Other

Not pregnant
No implanted magnetic device
No severe claustrophobia
No other contraindications to MRI
No psychiatric, psychological, or other condition that would preclude informed consent

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

At least 6 months since prior anticancer chemotherapy

Endocrine therapy

No concurrent therapeutic hormonal therapy, tamoxifen, or aromatase inhibitors (preventive therapy allowed)

Radiotherapy

Not specified

Surgery

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00058058

Show 21 Study Locations

Sponsors and Collaborators

American College of Radiology Imaging Network

National Cancer Institute (NCI)

Investigators

Study Chair:

Constance Lehman, MD, PhD

Seattle Cancer Care Alliance

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Lehman CD, Gatsonis C, Kuhl CK, Hendrick RE, Pisano ED, Hanna L, Peacock S, Smazal SF, Maki DD, Julian TB, DePeri ER, Bluemke DA, Schnall MD; ACRIN Trial 6667 Investigators Group. MRI evaluation of the contralateral breast in women with recently diagnosed breast cancer. N Engl J Med. 2007 Mar 29;356(13):1295-303. Epub 2007 Mar 28.

Study ID Numbers:	CDR0000285698, ACRIN-6667
Study First Received:	April 7, 2003
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00058058 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

ductal breast carcinoma in situ
invasive ductal breast carcinoma
invasive lobular breast carcinoma
breast cancer in situ
stage I breast cancer

stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on November 22, 2009