This trial is active, not recruiting.

Condition breast cancer
Treatment computed tomography and mammography and tomosynthesis
Phase phase 0
Sponsor University of California, Davis
Collaborator Hologic, Inc.
Start date November 2010
End date November 2016
Trial size 112 participants
Trial identifier NCT01852032, 221183


The purpose of this study is to compare the imaging performance of an investigational breast computed tomography (CT) scanner, built at UC Davis, with that of an FDA-Approved breast tomosynthesis scanner (capable of producing standard 2-D mammography and 3-D tomosynthesis images), built by Hologic, Incorporated, in a group of patients with suspected breast cancer.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
(Active Comparator)
Tomosynthesis is done first
computed tomography and mammography and tomosynthesis
Computed Tomography and Mammography and Tomosynthesis
(Active Comparator)
CT is done first
computed tomography and mammography and tomosynthesis
Computed Tomography and Mammography and Tomosynthesis

Primary Outcomes

Tumor conspicuity
time frame: Day 1

Secondary Outcomes

Compare the number of lesions and Radiation dose
time frame: Day 1
Comparison of radiation doses
time frame: Day 1

Eligibility Criteria

Female participants at least 35 years old.

Inclusion Criteria: - 35 years of age or older - While male patients will not be explicitly excluded, it is expected that all patients in this study will be women - Diagnostic findings from prior mammography suspicious for, or highly suggestive of, breast malignancy -BIRADS (Breast Imaging Reporting and Data System) categories 4 and 5 - Scheduled for ultrasound or stereotactic core biopsy - Ability to lie still on a table top for up to 10 minutes, longer than the typical breast CT duration. - Ability to understand risks, procedures, and benefits involved Exclusion Criteria: - Recent breast biopsy - History of breast augmentation implant - Pregnant or Positive urine pregnancy test (UPT) or currently breast-feeding - History of moderate or severe adverse reaction to iodinated contrast injection - Recent serum creatinine ≥ 1.5 mg/dL - History of Diabetes Mellitus - Currently taking Glucophage or Glucovance (Metformin) - History of chronic asthma - History of allergy to iodine - Multiple food and/or drug allergy - Renal disease - History of pulmonary disease, phobia of breath holding, or other condition that could prevent the subject from being able to perform the 16 second breath hold

Additional Information

Official title Computed Tomography Versus Standard 2D Mammography Versus 3D Tomosynthesis
Principal investigator John M Boone, PhD
Description The primary aim of this study is the comparison of tumor conspicuity on images taken by both systems (computed tomography versus standard 2-D mammography versus 3-D tomosynthesis) using a ten point conspicuity scale as the end-point. Secondary aims will be to compare the number of lesions detected by the two systems, and to compare the estimated radiation dose of the two systems.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by University of California, Davis.