Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00010172

Trial Description

start of 1:1-Block title

Title

Potential induction of DNA double strand breaks through MRI

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

DSB-MRT

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

[---]*

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

In the field of ionizing radiation has been able to in different in vitro and in vivo studies demonstrated that the use of radiological image acquisition techniques using X-rays (computed tomography, conventional X-ray) is associated with a dose-dependent formation of DNA double-strand breaks (DNA DSB) and consequently, increasing the risk of cancer.
Ionizing radiation, a dose-dependent effect on the cell viability and survival has been described in publications. Based on the CellTiter-Blue Cell Viability assays, in which the proportion of metabolically active cells can be found on the turnover of the redox dye resazurin, is the rate of viable cells 24 and 48 hours after CT / MRI are determined.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00010172
  •   2016/03/30
  •   [---]*
  •   yes
  •   Approved
  •   38/14, Ethikkommission der Medizinischen Fakultät der Otto-von-Guericke-Universität Magdeburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   RAD244  (internes Register)
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   C20 -  Malignant neoplasm of rectum
  •   C18 -  Malignant neoplasm of colon
  •   C22 -  Malignant neoplasm of liver and intrahepatic bile ducts
  •   C50 -  Malignant neoplasm of breast
  •   Indication of Imaging in case of MRI or CT
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   The study aims to show a potential threat from patients undergoing MRI scan. Therefore blood samples are drawn immediately before an examination, as well as immediately after and about 30 minutes after an examination in all study arms. a)MRI 7 Tesla
  •   The study aims to show a potential threat from patients undergoing MRI scan. b) MRI 3 Tesla
  •   The study aims to show a potential threat from patients undergoing MRI scan. c) MRI 1.5 Tesla
  •   The study aims to show a potential threat from patients undergoing MRI scan. d)MRI 1 Tesla
  •   The study aims to show a potential threat from patients undergoing MRI scan.e) as a control group CT (control)
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Maybe caused by the magnetic resonance imaging cellular damage. This expected dose-dependent effect on the cell viability and the survival rate is analyzed.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

significant difference in the mean number of dna double strand breaks

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2014/04/09
  •   40
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

routine clinical MRI- or CT-examination. Inclusion in 7T knee mri study.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

radio- or chemotherapy in the last 12 weeks
• Lymphoma or leucemia in the past or present
• x-ray-examination or scintigraphy in the last three days
• age of patient over 18 years

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Magdeburg
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Institut für Experimentelle Physik/Leibniz-Institut für Neurobiologie (LIN)Biomedizinische Magnetresonanz(BMMR)
    • Mr.  Prof.  Oliver  Speck 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Universitätsklinikum Magdeburg A.ö.R.Immunologie
    • Mr.  Prof.  Dirk  Reinhold 
    • Leipziger Strasse 44
    • 39120  Magdeburg
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Klinik für Radiologie und NuklearmedizinUniversität Magdeburg
    • Mr.  Dr.  Björn  Friebe 
    • Leipziger Strasse 44
    • 39120  Magdeburg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Klinik für Radiologie und Nuklearmedizin
    • Ms.  Christel  Besseler 
    • Leipziger Strasse 44
    • 39120  Magdeburg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Klinik für Radiologie und NuklearmedizinUniversität Magdeburg
    • Mr.  Prof.  Jens  Ricke 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting suspended on temporary hold
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.