NCT00474604

Breast MRI in Women With Known or Suspected Breast Cancer and in Healthy Participants

MRI Evaluation of Breast Tumor Growth and Treatment Response

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 209 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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: Quantitative, multi-parametric magnetic imaging methods will be employed for breast imaging for the following subjects: * Group A: Healthy volunteers who undergo up to 3 breast MRIs over 6 weeks. * Group B: Patients diagnosed with breast cancer who will: 1) undergo preoperative breast MRI followed by definitive surgery or 2) undergo MRI prior to initiating neoadjuvant chemotherapy, at 1-2 weeks after initiation of chemotherapy, and prior to definitive surgery. 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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	diffusion-weighted magnetic resonance imaging	A scan will be performed.
PROCEDURE	dynamic contrast-enhanced magnetic resonance imaging	A scan will be performed.
PROCEDURE	magnetic resonance spectroscopic imaging	A scan will be performed.

Timeline

• Start date: 2006-03-01
• Primary completion: 2023-04-25
• Completion: 2023-04-25
• First posted: 2007-05-17
• Last updated: 2023-11-27

Locations

1 site across 1 country: United States