Breast MRI in Women With Known or Suspected Breast Cancer and in Healthy Participants - Full Text View

Sponsors and Collaborators:	Vanderbilt-Ingram Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00474604

Purpose

RATIONALE: Diagnostic procedures, such as MRI, may help diagnose breast cancer. It may also help doctors predict a patient's response to treatment.

PURPOSE: This clinical trial is studying breast MRI in women with known or suspected breast cancer and in healthy participants.

Condition	Intervention
Breast Cancer	Procedure: diffusion tensor imaging Procedure: dynamic contrast-enhanced magnetic resonance imaging Procedure: magnetic resonance spectroscopic imaging

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer MRI Scans

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label
Official Title:	MRI Evaluation of Breast Tumor Growth and Treatment Response

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

Primary Outcome Measures:

Feasibility of using advanced, quantitative, multiparametric magnetic resonance imaging methods for characterizing breast tumors and predicting treatment response [ Designated as safety issue: No ]
Identification of surrogate biomarkers that can guide diagnosis and treatment of breast cancer [ Designated as safety issue: No ]
Correlation of biochemical data obtained from magnetic resonance analysis with clinical, radiological, and pathological findings [ Designated as safety issue: No ]
Establishment of an imaging data bank [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	March 2006
Estimated Primary Completion Date:	March 2014 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Develop and combine advanced, quantitative, multiparametric magnetic resonance imaging methods (i.e., dynamic contrast-enhanced MRI [DCE-MRI], diffusion-weighted MRI [DW-MRI], and magnetic resonance spectroscopy [MRS]) to characterize breast tumors in women with known or suspected breast cancer.
Identify surrogate biomarkers that can guide diagnosis and treatment of breast cancer using these methods.
Correlate biochemical information obtained from magnetic resonance analysis with clinical, radiologic, and pathologic findings in these patients.
Establish an imaging data bank that includes information on DCE-MRI, DW-MRI, and MRS findings in these patients and in healthy participants.

OUTLINE: Patients are stratified according to treatment plan (definitive surgery vs neoadjuvant chemotherapy). Patients are assigned to groups 1 or 2.

Healthy participants are assigned to group 3.

Group 1 : Patients undergo preoperative breast MRI followed by definitive surgery.
Group 2: Patients undergo MRI measurement of tumor volume prior to initiating neoadjuvant chemotherapy, 1-2 weeks after initiation of chemotherapy, and prior to definitive surgery.
Group 3: Healthy participants undergo up to 3 breast MRIs over 6 weeks. Clinical information, including radiologic and pathologic data, on all patients is collected for inclusion in the imaging data bank.

After completion of the study, patients and healthy participants are followed periodically.

PROJECTED ACCRUAL: A total of 150 patients and healthy participants will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

DISEASE CHARACTERISTICS:

Meets 1 of the following criteria:
- Healthy participant
- Patient with known or suspected breast disease
Hormone receptor status unknown

PATIENT CHARACTERISTICS:

Female
Menopausal status not specified
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No patients who are acutely ill or deemed ineligible for study participation by their treating physician
No contraindication to MRI, including any of the following:
- Breast volume
- Obesity
- Foreign ferromagnetic materials in the body

PRIOR CONCURRENT THERAPY:

No concurrent gadopentetate dimeglumine in patients or healthy participants with known prior allergic reaction to the MRI contrast agent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00474604

Locations

United States, Tennessee
Vanderbilt-Ingram Cancer Center - Cool Springs	Recruiting
Nashville, Tennessee, United States, 37064
Contact: Bapsi Chak 615-322-2555
Vanderbilt-Ingram Cancer Center at Franklin	Recruiting
Nashville, Tennessee, United States, 37064
Contact: Bapsi Chak 615-322-2555
Vanderbilt-Ingram Cancer Center	Recruiting
Nashville, Tennessee, United States, 37232-6838
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center 800-811-8480

Sponsors and Collaborators

Vanderbilt-Ingram Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

A. Bapsi Chakravarthy, MD

Vanderbilt-Ingram Cancer Center

More Information

Additional Information:

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

Publications:

Yankeelov TE, Lepage M, Chakravarthy A, Broome EE, Niermann KJ, Kelley MC, Meszoely I, Mayer IA, Herman CR, McManus K, Price RR, Gore JC. Integration of quantitative DCE-MRI and ADC mapping to monitor treatment response in human breast cancer: initial results. Magn Reson Imaging. 2007 Jan;25(1):1-13. Epub 2006 Nov 21.

Study ID Numbers:	CDR0000544576, VU-VICC-BRE-0588, VU-VICC-IRB-051230
Study First Received:	May 16, 2007
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00474604 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

breast cancer
breast cancer

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Healthy
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009