Breast Cancer
Conditions
Keywords
MBI, Molecular Breast Imaging, Breast, Breast Cancer, Molecular Imaging
Brief summary
The purpose of this study is to compare two types of radioactive drugs to see if they provide the same or different information about any disease that may be present in the participants breast.
Interventions
None listed
Sponsors
GE Healthcare
Michael O'Connor
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Have a lesion on mammogram, ultrasound or breast MRI that measured \< 15 mm in diameter, is considered suggestive or highly suggestive of malignancy according to the Breast Imaging Reporting and Data System Atlas criteria (BIRADS 4b, 4c or 5), and is scheduled for biopsy (needle biopsy and/or surgical biopsy). OR * Have a lesion on mammogram, ultrasound or breast MRI that measured \> 15 mm in diameter, is known to be malignant and is scheduled for surgery. * Patient age \> 18 years of age. * Have a negative pregnancy test on the first day of the study, or must be postmenopausal or surgically sterilized.
Exclusion criteria
* Patients will be excluded if they have a small lesion (\< 15 mm) and have undergone prior needle biopsy of the lesion (such biopsy may effectively remove all or part of the lesion and angiogenesis associated with wound healing might confound imaging results with 99mTc-NC100692). * Patient's pregnancy is not negative on the first day of the study, or the patient is unable to complete the pregnancy test * Patient is unable to sit on a chair for 40 minutes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evidence of disease confirmed by surgery, or benign disease confirmed by biopsy | 30 days |
Countries
United States
Outcome results
None listed