Status:
COMPLETED
Chemotherapy Monitoring With Breast Computed Tomography (CT)
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Brief Summary
The purpose of this study is to determine if dedicated breast computed tomography can be used successfully to monitor tumor response in breast cancer patients undergoing neoadjuvant chemotherapy.
Detailed Description
Before undergoing surgery to remove the tumor, it is common for breast cancer patients to first undergo chemotherapy or hormonal therapy. The main goal of the therapy is to reduce the size of the tumo...
Eligibility Criteria
Inclusion
- 1 Eligibility Criteria
- All subjects will be women at least 18 years of age that will undergo standard or research pre-operative hormonal therapy for breast cancer before lumpectomy or mastectomy.
- Women who have undergone pre treatment breast MR imaging to verify that no additional findings are present.
- 2 Ineligibility Criteria
- Subject does not meet any of the inclusion criteria
- Women with suspected or confirmed pregnancy
- Women who have had bilateral mastectomy
- Women who are unable to remain in a prone position on the BCT system for the required amount of time
- Women who cannot give informed consent
- Women with metastasis
- Male subjects
- Women with implants
- Women with breast augmentation, except for unilateral augmentation done for prior mastectomy
- Women who are allergic to iodine
- Women with physical limitations such as, but not limited to: frozen shoulder, recent heart surgery, pace maker, neck problems or any other condition that would prohibit them from lying face down
- Women who have had problems or reactions to contrast, such as nausea/vomiting, itching, hives, B/P changes, respirator distress, cardiac arrest.
- Women with history of Diabetes, kidney disease, kidney surgery, dialysis, heart disease-such as Congestive Heart Failure, Multiple Myeloma, Sickle Cell Anemia, Lupus, Rheumatoid Arthritis or other Autoimmune disease, recent surgery, chemotherapy, dehydration, high use of NSAIDs such as Ibuprofen
Exclusion
Key Trial Info
Start Date :
July 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00808041
Start Date
July 1 2009
End Date
July 1 2015
Last Update
July 23 2015
Active Locations (1)
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1
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322