Computed Tomography Laser Mammography Breast Imaging Device

Breast Cancer Clinical Trial

— CTLM  

Official title:

Computed Tomography Laser Mammography Breast Imaging Device Model 1020

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00589043
• Other study ID #: NA at present
• Status: Not yet recruiting
• Phase: N/A
• First received: December 24, 2007
• Last updated: August 24, 2015
• Start date: October 2015
• Est. completion date: November 2016

Study information

• Verified date: August 2015
• Source: Imaging Diagnostic Systems
• Contact: Debra Wood
• Phone: 954-581-9800
• Email: dwood[@]imds.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate the sensitivity and specificity of the CTLM system when used adjunctively with mammography compared to mammography alone in the heterogeneously and extremely dense breast population.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Female

• 21 and over

• Heterogeneously or extremely dense breast

• Schedule for biopsy

• Gave informed consent

Exclusion Criteria:

• Mammogram not performed within the last 60 days

• Open lesions on the breast

• Previous breast biopsy within 60 days of the CTLM scan

• Surgical deformity of breasts

• Commercial Tattoos

• Protoporphyria

• Lactating

Study Design

N/A

Related Conditions & MeSH terms

• Breast Cancer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Imaging Diagnostic Systems