Comparison of MRI and Molecular Breast Imaging in Breast Diagnostic Evaluation

Breast Cancer Clinical Trial

— MBI  

Official title:

Comparison of Magnetic Resonance Imaging and Molecular Breast Imaging in Breast Diagnostic Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00591864
• Other study ID #: 07-003397
• Status: Completed
• Phase: N/A
• First received: December 21, 2007
• Last updated: June 6, 2014
• Start date: September 2008
• Est. completion date: December 2010

Study information

• Verified date: June 2014
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the sensitivity of Molecular Breast Imaging (MBI) relative to MRI of the breast in patients undergoing MRI for a clinical concern, or abnormal diagnostic mammogram and/or ultrasound study.

Description:

Background: Breast MRI has excellent sensitivity, but is very expensive and suffers from low specificity. Additional benign biopsies are prompted by MRI in 24-40% of patients. Molecular Breast Imaging (MBI) is a new nuclear medicine technique developed at Mayo. Preliminary MBI results indicate a sensitivity of ~88% for the detection of tumors < 10 mm. The cost of an MBI procedure is expected to be a factor of 5 less than an MRI examination.

Hypothesis: MBI has a comparable sensitivity to MRI at a significantly lower cost.

Study Design: A total of 120 patients will be studied. All patients will have been scheduled for bilateral breast MRI at Mayo Clinic Rochester for a clinical concern, problem solving, or abnormal mammogram and/or ultrasound study. All patients will undergo MBI within 3 weeks of the MRI examination.

Potential Outcomes: This study will provide valuable information on the sensitivity of MBI relative to MRI, and to determine if this new technique can be eventually developed as an alternative to MRI for problem solving.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years and older

Eligibility

Inclusion Criteria:

• This study will include a population of women aged 25 or older who are scheduled for a breast MRI examination at MAYO CLINIC ROCHESTER.

• Patients must not be lactating or pregnant.

• All women of child-bearing potential must have had a negative urine pregnancy test result within 2 days prior to the MBI study.

• women who are scheduled for a breast MRI examination for a clinical concern, problem solving or for further evaluation of invasive breast cancer (e.g. pre-operative staging of known breast cancer).

Exclusion Criteria:

• They are unable to understand and sign the consent form

• They are pregnant or lactating

• They are physically unable to sit upright and still for 40 minutes.

• The breast MRI is for screening purposes or to determine the status of breast augmentation.

• They have undergone breast surgery within the previous year

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Device:
• Molecular Breast Imaging
Molecular breast Imaging is a new nuclear medicine technique for imaging the breast. It uses small filed of view semiconductor-based gamma cameras that use Cadmium Zinc Telluride detectors. These have superior spatial and energy resolution to conventional sodium iodide detectors.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity on the Per Patient Level	Sensitivity is the number of women with breast cancer detected per number of women with breast cancer diagnosed by surgery or biopsy.	within 1 week of surgery or biopsy	No
Secondary	Sensitivity on the Per Tumor Level	Number of tumors detected per number of tumors diagnosed on surgery or biopsy.	within 1 week of surgery or biopsy	No
Secondary	Specificity	The number of women with negative imaging test per number of women without cancer.	at least one year following imaging	No

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