Evaluation of Breast CT
35 Years
N/A
Female
Breast Cancer
Trial Information
Evaluation of Breast CT
Contrast injections are used to identify breast cancer lesions in clinical procedures, most
notably breast MRI (gadolinium contrast agent). Other investigators have demonstrated the
utility of iodine contrast agent injection for breast cancer delineation in projection
mammography techniques, using both dual energy subtraction (Lewin) and temporal subtraction
(Yaffe) to highlight the visualization of the breast tumor. A total of 100 of the 300
patient subjects will undergo contrast agent injection.
The Specific Aims associated with the Phase II patient trial involve the comparison between
the screen-film (or digital) mammograms (obtained through routine clinical screening) with
the images created by the breast CT scanner.
Inclusion Criteria:
- Normal Adult Volunteers
- Age at least 35 years old
- No known or suspected breast disease
- Not pregnant or breast-feeding
- Ability to lie motionless for up to 5 minutes
Patient Volunteers
- Age at least 35 years old
- Diagnostic findings from prior mammography highly suggestive of breast malignancy
(BI- RADS® category 4) or known biopsy-proven malignancy (Breast Imaging-Reporting
And Data System (BI-RADS®) category 5)
- Not pregnant or breast-feeding
- Ability to lie motionless for up to 5 minutes
Patient Volunteers/Contrast Enhancement Sub-group
- Age at least 35 years old
- Suspected or known biopsy-proven malignancy (BI-RADS® category 4 & 5)
- Not pregnant or breast-feeding
- Ability to lie motionless for up to 5 minutes
Exclusion Criteria:
- Normal Adult Volunteers
- Symptomatic of any breast abnormality
- Positive urine pregnancy test or currently breast-feeding
- Inability to understand the risks and benefits of the study
Patient Volunteers
- Recent breast biopsy
- Positive urine pregnancy test or currently breast-feeding
- Inability to understand the risks and benefits of the study
Patient Volunteers/Contrast Enhancement Sub-group
- History of moderate or severe reaction to contrast agent injection
- History of Allergy to Iodine
- History of multiple food and/or drug allergy
- Currently taking Glucophage or Glucovance (Metformin)
- History of Chronic Asthma
- History of Diabetes Mellitus
- Renal (kidney) disease, or solitary kidney
- Recent lab tests showing elevated serum creatinine (≥ 1.5 mg/dL)
- Positive urine pregnancy test or currently breast-feeding
- Inability to understand the risks and benefits of the study
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
The Specific Aims associated with the Phase II patient trial involve the comparison between the screen-film (or digital) mammograms (obtained through routine clinical screening) with the images created by the breast CT scanner.
Outcome Time Frame:
5 years
Safety Issue:
Yes
Principal Investigator
John M. Boone, Ph.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
UC Davis Dept. of Radiology
Authority:
United States: Institutional Review Board
Study ID:
200412728
NCT ID:
NCT00584233
Start Date:
December 2004
Completion Date:
December 2015
Related Keywords:
- Breast Cancer
- breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| UC Davis Medical Center | Sacramento, California 95817 |
