MedPath

Pre-biopsy With Dynamic Acquisitions

Completed
Conditions
Breast Cancer
Registration Number
NCT00943644
Lead Sponsor
Mayo Clinic
Brief Summary

This study is being done to test the ability of an investigational mammography camera to find small tumors in patients' breasts.

Detailed Description

If you agree to take part in this study, you will be asked to remove your clothes from the waist up and put on a gown. A female technologist will give you an injection of Tc-99m sestamibi in a vein in your arm. This is a drug routinely used for breast imaging. About 10 minutes after your injection, you will be asked to sit in a chair for about 40 minutes. The technologist will position your breast between two small cameras. The cameras will apply a very light compression to your breast to make sure there is no movement during the picture. We will take two pictures of each breast. Each picture takes 10 minutes. You will also be asked to fill out a short questionnaire. If you are found to have additional breast lesions, your doctor and radiologist will be notified so that additional imaging or biopsies can be performed.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
185
Inclusion Criteria
  • Have a lesion on Mammogram, Ultrasound or MRI that measured < 2 cm and considered suspicious or suggestive of malignancy
  • Scheduled for biopsy of lesion
  • > 18 years of age
  • Negative pregnancy test, postmenopausal, or surgically sterilized
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Exclusion Criteria
  • Prior needle biopsy
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To determine the sensitivity of the dual-head system relative to single-head for detection of sub 10 mm breast lesions, and to determine the number of images that need to be acquired.2 years
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Mayo Clinic

🇺🇸

Rochester, Minnesota, United States

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