Contrast-Enhanced Cone Beam Breast CT for Diagnostic Breast Imaging

PHASE2/PHASE3TerminatedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

September 10, 2018

Primary Completion Date

September 1, 2021

Study Completion Date

September 1, 2021

Conditions
Breast Cancer
Interventions
RADIATION

Contrast Enhanced Cone Beam Breast CT Scan

"* Pre-contrast scan~* Begin contrast injection (and saline chaser)~* Post-contrast Scan. Start time of post-contrast CE-CBBCT scan is 90-200 seconds after start of injection, depending on method of contrast delivery (bolus vs hand injection)"

DRUG

Contrast Dye, Iodinated

"1.5-2ml/kg body weight (100 ml maximum) of a low osmolar, nonionic, 300-350 mgI/ml iodinated contrast agent, will be injected at a rate of \~2.0 ml/s, for a total injection time of 30-60 seconds (for a 50 kg subject). This will be immediately followed by a saline chaser from 20 to 40 ml at \~2 ml/s (20 seconds) to maximize dynamic enhancement."

Trial Locations (2)

14623

UR Medicine Breast Imaging, Rochester

37909

Knoxville Comprehensive Breast Center, Knoxville

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Koning Corporation

INDUSTRY