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Computed Tomography Laser Mammography Breast Imaging Device

Computed Tomography Laser Mammography Breast Imaging Device Model 1020

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00589043
Acronym
CTLM
Enrollment
600
Registered
2008-01-09
Start date
2015-10-31
Completion date
2016-11-30
Last updated
2015-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief 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.

Interventions

None listed

Sponsors

Imaging Diagnostic Systems
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No

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

Contacts

Primary ContactDebra Wood
dwood@imds.com954-581-9800

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026