Status:
COMPLETED
Detection of Aggressive Breast Tumors Using Tc-99m-NC100692
Lead Sponsor:
Michael O'Connor
Collaborating Sponsors:
GE Healthcare
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-90 years
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00888589
Start Date
May 1 2008
End Date
February 1 2014
Last Update
March 27 2014
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905