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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Vanderbilt-Ingram Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
A Bapsi Chakravarthy, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00474604
First received: May 16, 2007
Last updated: July 14, 2014
Last verified: July 2014
  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-weighted magnetic resonance imaging
Procedure: dynamic contrast-enhanced magnetic resonance imaging
Procedure: magnetic resonance spectroscopic imaging

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: MRI Evaluation of Breast Tumor Growth and Treatment Response

Resource links provided by NLM:


Further study details as provided by Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:
  • 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 [ Time Frame: at study entry (healthy volunteers), pre-surgical and pre- and post-chemotherapy (breast cancer patients) ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Correlation of biochemical data obtained from magnetic resonance analysis with clinical, radiological, and pathological findings [ Time Frame: After completion of surgical, chemotherapeutic, and radiologic treatments ] [ Designated as safety issue: No ]
    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 [ Time Frame: After completion of all MRI procedures ] [ Designated as safety issue: No ]
    Results of advanced MRI imaging methods for subjects


Estimated Enrollment: 300
Study Start Date: March 2006
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Participants without breast cancer 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.
Experimental: Participants with breast cancer 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.

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.

  Eligibility

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

Inclusion criteria:

Women who satisfy the following conditions are the only subjects who will be eligible for this study:

  • Normal volunteers
  • Subjects with known or suspected breast disease
  • Subjects must have signed an approved consent form.
  • Subjects must be ≥ 18 years old.
  • The protocol nurse will check with the patient that there is no h/o kidney disease
  • Normal creatinine and estimated GFR* within 30 days under the following circumstances

    • Had abnormal creatinine in the last 60 days
    • Are over 60 years of age
    • Has received chemotherapy within the past 30 days
    • Has diabetes, HIV, renal disease or hx of renal cancer
  • * GFR will be calculated using: http://www.kidney.org/professionals/kdoqi/gfr_calculator.cfm
  • Patients with an eGFR>90ml/min reported within 30 days, and who have not had intervening chemotherapy or other treatment or condition that might deteriorate renal function, may receive any gadolinium agent.

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"
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: VICC Clinical Trials Information Program 800-811-8480

Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center - Cool Springs Recruiting
Nashville, Tennessee, United States, 37064
Contact: VICC Clinical Trials Information Program    800-811-8480      
Principal Investigator: Bapsi Chak, MD         
Vanderbilt-Ingram Cancer Center at Franklin Recruiting
Nashville, Tennessee, United States, 37064
Contact: VICC Clinical Trials Information Program    800-811-8480      
Principal Investigator: Bapsi Chak, MD         
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232-6838
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center    800-811-8480      
Principal Investigator: Bapsi Chak, MD         
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
Study Chair: A. Bapsi Chakravarthy, MD Vanderbilt-Ingram Cancer Center
  More Information

Additional Information:
Publications:
Responsible Party: A Bapsi Chakravarthy, MD, Associate Professor; Radiation Oncologist, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00474604     History of Changes
Other Study ID Numbers: VICC BRE 0588, P30CA068485, VU-VICC-BRE-0588, VU-VICC-IRB-051230
Study First Received: May 16, 2007
Last Updated: July 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Vanderbilt-Ingram Cancer Center:
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 28, 2014