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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: diffusion-weighted magnetic resonance imaging; Procedure: dynamic contrast-enhanced magnetic resonance imaging; Procedure: magnetic resonance spectroscopic imaging

• Registration Number: NCT00474604
• Lead Sponsor: Vanderbilt-Ingram Cancer Center

Brief 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.

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2007-05-16
• Study First Submitted QC: 2007-05-16
• Study First Posted: 2007-05-17
• Primary Completion: 2023-04-25
• Study Completion: 2023-04-25
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 209

Inclusion Criteria

Not provided

Exclusion Criteria

• Children will be excluded from this study.
• Pregnant women and women who are breast feeding will be excluded from this study. (The Vanderbilt University Medical Center radiology "MRI Procedure Screening Form" will be used to identify and exclude subjects who are pregnant or breastfeeding. A urine pregnancy test/or serum beta HCG will also be performed for each pre-menopausal subject.)
• Subjects found to have any constitutionally present non-MR compatible ferromagnetic materials will be excluded from this study.
• Patients who are acutely ill who are deemed by their treating physician as not suitable candidates for this study
• Subjects for whom an MRI is technically not feasible (e.g. breast volume, obesity)
• Subjects who have vascular access ports or other implanted devices rated as anything other than "Safe" or "Conditional 6"

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Participants without breast cancer	dynamic contrast-enhanced magnetic resonance imaging	-
Participants without breast cancer	diffusion-weighted magnetic resonance imaging	-
Participants without breast cancer	magnetic resonance spectroscopic imaging	-
Participants with breast cancer	diffusion-weighted magnetic resonance imaging	-
Participants with breast cancer	dynamic contrast-enhanced magnetic resonance imaging	-
Participants with breast cancer	magnetic resonance spectroscopic imaging	-

Primary Outcome Measures

Name	Time	Method
Feasibility of advanced, quantitative, multi-parametric magnetic resonance imaging (MRI) methods for characterizing breast tumors to develop potential surrogate imaging markers for diagnosis and prediction of treatment response	on-study date and at 6 months, up to 4 years	Quantitative, multi-parametric MRI imaging methods include Dynamic Contrast MRI, Diffusion Weighted MRI, and Magnetic Resonance Spectroscopy. Patients will include healthy female volunteers and women diagnosed with breast cancer. Time frames begin at study entry (healthy volunteers) , pre-surgical and pre- and post-chemotherapy (breast cancer patients)

Secondary Outcome Measures

Name	Time	Method
Correlation of biochemical data obtained from magnetic resonance analysis with clinical, radiological, and pathological findings	at 6 months	Biochemical data from advanced MRIs are compared and contrasted with findings from patients' clinical, chemotherapeutic, and radiologic treatments for breast cancer.
Establishment of an imaging data bank	at 6 months	Results of advanced MRI imaging methods for subjects assessed after completion of all MRI procedures

Trial Locations

Locations (1)

Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States