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Computed Tomography Laser Mammography Breast Imaging Device (CTLM)

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
Imaging Diagnostic Systems
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Breast Cancer

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    December 24, 2007
    Last Updated
    August 24, 2015
    Sponsor
    Imaging Diagnostic Systems
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00589043
    Brief Title
    Computed Tomography Laser Mammography Breast Imaging Device
    Acronym
    CTLM
    Official Title
    Computed Tomography Laser Mammography Breast Imaging Device Model 1020
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    August 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2015 (undefined)
    Primary Completion Date
    November 2016 (Anticipated)
    Study Completion Date
    November 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Imaging Diagnostic Systems

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer

    7. Study Design

    Enrollment
    600 (Anticipated)

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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 Population Description
    Heterogeneous or extremely dense breast patient population scheduled for biopsy
    Sampling Method
    Non-Probability Sample
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Debra Wood
    Phone
    954-581-9800
    Email
    dwood@imds.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David Jin, MD
    Organizational Affiliation
    Imaging Diagnostic Systems
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Computed Tomography Laser Mammography Breast Imaging Device

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