Comparison of MRI and Molecular Breast Imaging in Breast Diagnostic Evaluation

NCT00591864 | Completed Results

• 1 other identifier: 07-003397
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

Benign breast disease; Breast; MRI; Mammography; Ultrasound; Molecular Breast Imaging; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Sensitivity on the Per Tumor Level

  within 1 week of surgery or biopsy

• Specificity

  at least one year following imaging

Interventions

Molecular Breast Imaging DEVICE

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.

Eligibility Criteria

• Age: 25 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• United States Department of Defense: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic News Blog
• Mayo Clinic You Tube Channel

MeSH Terms

Conditions

Breast Neoplasms; Cystic Fibrosis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Results Point of Contact

• Title: Amy Lynn Conners MD
• Organization: Mayo Clinic

MBI@mayo.edu

(507) 284-2511

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 11, 2008
• Study Start: September 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: July 9, 2014
• Results First Posted: July 9, 2014

Record last verified: 2014-06

Locations

US (1)