NCT07219797

Study of Monochromatic X-ray Mammography System

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Imagine Scientific, Inc. · Industry
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

A research study to find out if an investigational mammography machine is effective in producing high-quality images using a lower radiation dose than traditional mammography.

Detailed description

Prospective, single-arm, non-blinded, comparative/observational study. Phase 1: Verify operation of monochromatic system and optimize the monochromatic energies and exposure times for a range of breast thicknesses. Phase 2: Test the performance of the monochromatic system in comparison to traditional 2-D mammography for a range of clinical/imaging scenarios. Phase 3: Test the performance of the monochromatic system using reduced breast compression.

Conditions

• Breast Imaging
• Breast Cancer

Interventions

Type	Name	Description
DEVICE	2-D Monochromatic X-ray Mammography System	Monochromatic x-ray mammography system produces superior images as compared to conventional 2-D and 3-D mammography while using a lower radiation dose.

Timeline

• Start date: 2026-06-01
• Primary completion: 2027-03-01
• Completion: 2027-04-01
• First posted: 2025-10-22
• Last updated: 2026-03-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study