Study of Monochromatic X-ray Mammography System

Imagine Scientific, Inc.

Status: Not yet enrolling

Conditions: Breast Cancer; Breast Imaging

Treatments: Device: 2-D Monochromatic X-ray Mammography System

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07219797

Pro00115443

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 estimated patients

Sex: Female

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female
• 40 yrs of age or older
• Capable of giving informed consent
• Prior history of mammography

Exclusion criteria

• Pregnancy
• History of breast cancer surgery, including lumpectomy or mastectomy
• Currently undergoing treatment for breast cancer
• Previous breast augmentations

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

Test device vs standard of care

Experimental group

Description:

Demonstrate that a 2-D monochromatic x-ray mammography system can produce mammographic images using lower radiation dose, yet not inferior to conventional mammography.

Treatment:

Device: 2-D Monochromatic X-ray Mammography System