N/A N=23 Diagnostic

Computed Tomography Versus Standard 2D Mammography Versus 3D Tomosynthesis

Breast Cancer

Bottom Line

View on ClinicalTrials.gov: NCT01852032 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2018

Primary outcome: Primary: Beta of CT Coronal View — 1.75 power-law slope(B)

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Tomosynthesis Breast Scanning (Radiation); Breast CT Scanning (Radiation)
Age: Adult, Older Adult · 35+ yrs
Sex: Female
Sponsor: University of California, Davis
Primary completion: Mar 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Beta of CT Coronal View	1.75	—
PRIMARY Beta of CT Sagittal View	1.83	—
PRIMARY Beta of CT Axial View	1.79	—
PRIMARY Beta of Tomosynthesis Craniocaudal View	3.06	—
PRIMARY Beta of Tomosynthesis Medial Lateral Oblique View	3.10	—

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01852032). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.