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Evaluation of Breast CT


Phase 2
35 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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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 CenterSacramento, California  95817