NCT03354611

Contrast-Enhanced Cone Beam Breast CT for Diagnostic Breast Imaging

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Koning Corporation · Industry
• Sex: Female
• Age: 35 Years
• Healthy volunteers: Not accepted

Summary

Up to one hundred (100) female patients will be enrolled and consented to participate in the study. These women will be enrolled from screening assigned BIRADS 0, patient complaint, or referral for second opinion. The enrolled patient will accept CE-CBBCT scans within 4 weeks of her diagnostic mammography and before breast biopsy if biopsy is needed. The final diagnostic workup outcome of these enrolled patients needs to include at least 30 confirmed cancers cases.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-09-10
• Primary completion: 2021-09-01
• Completion: 2021-09-01
• First posted: 2017-11-28
• Last updated: 2023-03-16

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study