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Evaluation of the High-resolution, Contrast Enhanced Low-dose Breast-CT

Primary Purpose

BI-RADS 4, BI-RADS 5, BI-RADS 6

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Native and dynamic contrast-enhanced CT
Sponsored by
RWTH Aachen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for BI-RADS 4 focused on measuring low dose CT, contrast-enhanced, breast cancer screening, computer tomography

Eligibility Criteria

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

Inclusion Criteria:

Sub Study 1:

  • patients with mammographic or sonographic validated Breast Imaging Reporting and Data System (BI-RADS)-4 or BI-RADS-5-result or in BI-RADS-6-situation, i.e. with an already reliable carcinoma by punch biopsy, for which a clinical indication for a mamma-MRI consists.
  • Age >= 40
  • maintained renal function (MDRD with GFR >= 60 ml/min/1,73m²)
  • normal thyroid function, no clinical indication for an endocrine autonomy, normal TSH (not older than 8 weeks)
  • Persons which are able to give written consent and are aware of the nature, meaning and extent of the study
  • signed informed consent

Substudy 2:

  • patients with a doubtful and suspect clinical or mammographic or sonographic result (BI-RADS 3, 4a, 4b, 4c, 5) as well as patients with a reliable carcinoma by punch biopsy (BI-RADS 6), patients with high risk of breast cancer for which a clinical indication for a mamma-MRI consists.
  • Age >= 40
  • maintained renal function (MDRD with GFR >= 60 ml/min/1,73m²)
  • normal thyroid function, no clinical indication for an endocrine autonomy, normal TSH (not older than 8 weeks)
  • Persons which are able to give written consent and are aware of the nature, meaning and extent of the study
  • signed informed consent

Exclusion Criteria:

Substudy 1:

  • Pregnancy or lactation
  • Women with child-bearing potential without sufficient contraception
  • Age <40 years
  • Women with proven pathogenic Breast Cancer (BRCA) 1-mutation or heterozygote risk (>= 25%)
  • Hospitalization of patient ordered by the court or local authorities
  • Relationship of dependence or employment to sponsor or investigator

additionally the following criteria apply, if conducting the dynamic contrast-enhanced breast-CT

  • signs of a renal insufficiency (GFR < 60ml/min/1,73m²)
  • clinical signs or signs of the labor chemistry for endocrine autonomy (increase of TSH)
  • Patients with known allergies or intolerance reactions grade II or higher to contrast medium containing iodine

Substudy 2:

  • Pregnancy or lactation
  • Women with child-bearing potential without sufficient contraception
  • Age <40 years
  • Women with proven pathogenic BRCA 1-mutation or heterozygote risk (>= 25%)
  • Hospitalization of patient ordered by the court or local authorities
  • Relationship of dependence or employment to sponsor or investigator

additionally the following criteria apply, if conducting the dynamic contrast-enhanced breast-CT:

  • end stage or advanced renal insufficiency
  • clinical signs or signs of the labor chemistry for endocrine autonomy (increase of TSH)
  • Patients with known allergies or intolerance reactions grade II or higher to contrast medium containing iodine

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Native and dynamic contrast-enhanced CT

    Arm Description

    Patients will undergo a native high-resolution and a dynamic contrast-enhanced CT, both sides respectively.

    Outcomes

    Primary Outcome Measures

    Sub-Study 1: comparison of a-posteriori sensitivity using the native, contrast-enhanced or dynamic contrast-enhanced breast CT.
    By using the images diagnostic criteria for identification and characterization of the pathologic and physiologic changes of the female breast will be elaborated.

    Secondary Outcome Measures

    Comparison of biological value of the diagnosed carcinoma in dependence with its detection mode.
    Detection mode means the prospective visibility of a carcinoma in one or more independent imaging methods, respectively. Biological value will be calculated by amount of high and intermediate grade vs. low grade lesions, status of Ki-67 values, distribution of luminal a, luminal b, Her2/neu and basal, distribution of receptor status
    Substudy 2: sensitivity of the native and the contrast-enhanced or dynamic contrast-enhanced high-resolution low-dose CT in comparison to the conventional examination procedures
    Sub-study 2: specificity of the native and the contrast-enhanced or dynamic contrast-enhanced high-resolution low-dose CT in comparison to the conventional examination procedures
    Substudy 2: Positive Predictive Value (PPV) of the native and the contrast-enhanced or dynamic contrast-enhanced high-resolution low-dose CT in comparison to the conventional examination procedures
    Substudy 2: Negative Predictive Value (NPV) of the native and the contrast-enhanced or dynamic contrast-enhanced high-resolution low-dose CT in comparison to the conventional examination procedures

    Full Information

    First Posted
    June 3, 2016
    Last Updated
    June 14, 2016
    Sponsor
    RWTH Aachen University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02798562
    Brief Title
    Evaluation of the High-resolution, Contrast Enhanced Low-dose Breast-CT
    Official Title
    Evaluation of the High-resolution, Contrast Enhanced Low-dose Breast-CT
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2017 (undefined)
    Primary Completion Date
    January 2019 (Anticipated)
    Study Completion Date
    January 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    RWTH Aachen University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of this study is the clinical establishment of a native and contrast-enhanced computer tomography of the breast. The early detection of breast cancer is still a great challenge. Even though the implementation of the digital mammography combined with the mandatory screening-programs lead to significant improvements, sensitivity and specificity of these examinations need to be clearly classified as improvable. Generally, it is stated that the necessary transit from 2-D projected images to 3-D tomography will be crucially advantageous as magnetic resonance imaging has already shown. Similar or even major advantages can be expected by new approaches regarding CT with very high local resolution, better than 100µm in 3D and lower dose, under 5 Milligray (mGy), as demanded for a screening. A device that meets these demands and is also applicable for dynamic scans after intravenous administration of a contrast agent, has been developed with the support by the European Union (EU), German Research Foundation (DFG) and Federal Ministry of Education and Research (BMBF). Publications on technical and experimental results are already available. An evaluation in the clinical use is missing yet. The primary aim of this study is to evaluate systematically the performance of the native and dynamic, contrast-enhanced CT of the breast.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    BI-RADS 4, BI-RADS 5, BI-RADS 6, High Risk of Breast Cancer Which Indicates a Mamma-MRI
    Keywords
    low dose CT, contrast-enhanced, breast cancer screening, computer tomography

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    400 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Native and dynamic contrast-enhanced CT
    Arm Type
    Experimental
    Arm Description
    Patients will undergo a native high-resolution and a dynamic contrast-enhanced CT, both sides respectively.
    Intervention Type
    Device
    Intervention Name(s)
    Native and dynamic contrast-enhanced CT
    Primary Outcome Measure Information:
    Title
    Sub-Study 1: comparison of a-posteriori sensitivity using the native, contrast-enhanced or dynamic contrast-enhanced breast CT.
    Description
    By using the images diagnostic criteria for identification and characterization of the pathologic and physiologic changes of the female breast will be elaborated.
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    Comparison of biological value of the diagnosed carcinoma in dependence with its detection mode.
    Description
    Detection mode means the prospective visibility of a carcinoma in one or more independent imaging methods, respectively. Biological value will be calculated by amount of high and intermediate grade vs. low grade lesions, status of Ki-67 values, distribution of luminal a, luminal b, Her2/neu and basal, distribution of receptor status
    Time Frame
    2 years
    Title
    Substudy 2: sensitivity of the native and the contrast-enhanced or dynamic contrast-enhanced high-resolution low-dose CT in comparison to the conventional examination procedures
    Time Frame
    2 years
    Title
    Sub-study 2: specificity of the native and the contrast-enhanced or dynamic contrast-enhanced high-resolution low-dose CT in comparison to the conventional examination procedures
    Time Frame
    2 years
    Title
    Substudy 2: Positive Predictive Value (PPV) of the native and the contrast-enhanced or dynamic contrast-enhanced high-resolution low-dose CT in comparison to the conventional examination procedures
    Time Frame
    2 years
    Title
    Substudy 2: Negative Predictive Value (NPV) of the native and the contrast-enhanced or dynamic contrast-enhanced high-resolution low-dose CT in comparison to the conventional examination procedures
    Time Frame
    2 years

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Sub Study 1: patients with mammographic or sonographic validated Breast Imaging Reporting and Data System (BI-RADS)-4 or BI-RADS-5-result or in BI-RADS-6-situation, i.e. with an already reliable carcinoma by punch biopsy, for which a clinical indication for a mamma-MRI consists. Age >= 40 maintained renal function (MDRD with GFR >= 60 ml/min/1,73m²) normal thyroid function, no clinical indication for an endocrine autonomy, normal TSH (not older than 8 weeks) Persons which are able to give written consent and are aware of the nature, meaning and extent of the study signed informed consent Substudy 2: patients with a doubtful and suspect clinical or mammographic or sonographic result (BI-RADS 3, 4a, 4b, 4c, 5) as well as patients with a reliable carcinoma by punch biopsy (BI-RADS 6), patients with high risk of breast cancer for which a clinical indication for a mamma-MRI consists. Age >= 40 maintained renal function (MDRD with GFR >= 60 ml/min/1,73m²) normal thyroid function, no clinical indication for an endocrine autonomy, normal TSH (not older than 8 weeks) Persons which are able to give written consent and are aware of the nature, meaning and extent of the study signed informed consent Exclusion Criteria: Substudy 1: Pregnancy or lactation Women with child-bearing potential without sufficient contraception Age <40 years Women with proven pathogenic Breast Cancer (BRCA) 1-mutation or heterozygote risk (>= 25%) Hospitalization of patient ordered by the court or local authorities Relationship of dependence or employment to sponsor or investigator additionally the following criteria apply, if conducting the dynamic contrast-enhanced breast-CT signs of a renal insufficiency (GFR < 60ml/min/1,73m²) clinical signs or signs of the labor chemistry for endocrine autonomy (increase of TSH) Patients with known allergies or intolerance reactions grade II or higher to contrast medium containing iodine Substudy 2: Pregnancy or lactation Women with child-bearing potential without sufficient contraception Age <40 years Women with proven pathogenic BRCA 1-mutation or heterozygote risk (>= 25%) Hospitalization of patient ordered by the court or local authorities Relationship of dependence or employment to sponsor or investigator additionally the following criteria apply, if conducting the dynamic contrast-enhanced breast-CT: end stage or advanced renal insufficiency clinical signs or signs of the labor chemistry for endocrine autonomy (increase of TSH) Patients with known allergies or intolerance reactions grade II or higher to contrast medium containing iodine
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Verena Deserno, Dipl.-Biol., M.A.
    Phone
    +49 241 80-80092
    Email
    vdeserno@ukaachen.de
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Christiane Kuhl, Univ.-Prof. Dr. med.
    Organizational Affiliation
    Klinik für Diagnostische und Interventionelle Radiologie
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    21361181
    Citation
    Weigel M, Vollmar SV, Kalender WA. Spectral optimization for dedicated breast CT. Med Phys. 2011 Jan;38(1):114-24. doi: 10.1118/1.3523599.
    Results Reference
    background
    PubMed Identifier
    22482646
    Citation
    Nowak T, Hupfer M, Althoff F, Brauweiler R, Eisa F, Steiding C, Kalender WA. Time-delayed summation as a means of improving resolution on fast rotating computed tomography systems. Med Phys. 2012 Apr;39(4):2249-60. doi: 10.1118/1.3697533.
    Results Reference
    background
    PubMed Identifier
    22316498
    Citation
    Beister M, Kolditz D, Kalender WA. Iterative reconstruction methods in X-ray CT. Phys Med. 2012 Apr;28(2):94-108. doi: 10.1016/j.ejmp.2012.01.003. Epub 2012 Feb 10.
    Results Reference
    background
    PubMed Identifier
    20177029
    Citation
    Kuhl C, Weigel S, Schrading S, Arand B, Bieling H, Konig R, Tombach B, Leutner C, Rieber-Brambs A, Nordhoff D, Heindel W, Reiser M, Schild HH. Prospective multicenter cohort study to refine management recommendations for women at elevated familial risk of breast cancer: the EVA trial. J Clin Oncol. 2010 Mar 20;28(9):1450-7. doi: 10.1200/JCO.2009.23.0839. Epub 2010 Feb 22.
    Results Reference
    background
    PubMed Identifier
    18477789
    Citation
    Kuhl CK. The "coming of age" of nonmammographic screening for breast cancer. JAMA. 2008 May 14;299(18):2203-5. doi: 10.1001/jama.299.18.2203. No abstract available.
    Results Reference
    background
    PubMed Identifier
    17693177
    Citation
    Kuhl CK, Schrading S, Bieling HB, Wardelmann E, Leutner CC, Koenig R, Kuhn W, Schild HH. MRI for diagnosis of pure ductal carcinoma in situ: a prospective observational study. Lancet. 2007 Aug 11;370(9586):485-92. doi: 10.1016/S0140-6736(07)61232-X.
    Results Reference
    background

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    Evaluation of the High-resolution, Contrast Enhanced Low-dose Breast-CT

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