Breast Cancer
Conditions
Keywords
MBI, Breast, Breast Cancer
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.
Interventions
To determine the sensitivity of MBI
DEVICECZT semiconductor detectors
Dual headed CZT semiconductor detectors
Sponsors
Susan G. Komen Breast Cancer Foundation
Mayo Clinic
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Exclusion criteria
* Prior needle biopsy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed