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Evaluation of Breast CT

This study is currently recruiting participants.
Verified October 2012 by University of California, Davis
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
John M. Boone, PhD, University of California, Davis
ClinicalTrials.gov Identifier:
NCT00584233
First received: December 21, 2007
Last updated: October 29, 2012
Last verified: October 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the efficacy of breast computed tomography (CT) for breast cancer detection. Initially, up to 20 female volunteers who will likely have normal breasts (non-cancer) will be evaluated on the breast CT scanner prototype which has been fabricated over the last two years in the PI's laboratory. This group of volunteers will provide feedback as to the ergonomics of the scanner table, the breast immobilization hardware, etc. After this initial study, up to 300 women who have been identified as having suspicious lesions on their mammograms and who are scheduled for breast biopsy will be approached to see if they will participate in this study. If they agree, we will perform breast CT using the prototype scanner prior to their scheduled biopsy. 100 of the 300 subjects will undergo iodinated contrast administration for contrast-enhanced breast CT.


Condition Intervention Phase
Breast Cancer
 Radiation: computed tomography
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of Breast CT

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • 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. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: December 2004
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 3
Patient volunteers, contrast-enhanced
 Radiation: computed tomography
Computed tomography of both breasts. For 100 of the 280 patient subjects, CT scanning will be performed before and after an I.V. iodinated contrast injection (100 mL).
Other Name: Breast x-ray
Experimental: 2
Patient volunteers, non-contrast
 Radiation: computed tomography
Computed tomography of both breasts. For 100 of the 280 patient subjects, CT scanning will be performed before and after an I.V. iodinated contrast injection (100 mL).
Other Name: Breast x-ray
Experimental: 1
normal volunteers, non-contrast
 Radiation: computed tomography
Computed tomography of both breasts. For 100 of the 280 patient subjects, CT scanning will be performed before and after an I.V. iodinated contrast injection (100 mL).
Other Name: Breast x-ray

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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 (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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00584233

Locations
United States, California
UC Davis Medical Center Recruiting
Sacramento, California, United States, 95817
Contact: John M. Boone, Ph.D.     916-734-3158     jmboone@ucdavis.edu    
Principal Investigator: John M. Boone, Ph.D.            
Sponsors and Collaborators
University of California, Davis
National Institutes of Health (NIH)
Investigators
Principal Investigator: John M. Boone, Ph.D. UC Davis Dept. of Radiology
  More Information

No publications provided

Responsible Party: John M. Boone, PhD, Professor, University of California, Davis
ClinicalTrials.gov Identifier: NCT00584233     History of Changes
Other Study ID Numbers: 200412728
Study First Received: December 21, 2007
Last Updated: October 29, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by University of California, Davis:
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 16, 2013