Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00013571

Trial Description

start of 1:1-Block title

Title

Quantification of radiopharmkon concentration within the scitigraphis diagnostic via SPECT/CT (QRCS-1): a prospective data acquisition within clinical indicated examinations

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

Trial Acronym

QRCS/CT-1-BO

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

Comprehensive Short version

Until now, scintigraphy was not capable of an exact determination of radiopharmaceutical uptake in body tissue and organs. Due to technical advance single photon emission computed tomography combined with x-ray computed tomography (SPECT/CT) now allows the necessary corrections of the image information. In particular, detector properties are taken into account and the attenuation of radiation within the human body are corrected by using CT data. In this study, the image datasets from clinical SPECT/CT examinations of patients will additionally be revised with the new quantification methods. Thus, the concentration of the radiopharmacon in various body areas will be calculated exactly. No additional examinations of patients will be performed. In addition, disease specific data as well as treatment details and the clinical follow up will be collected, if available. Based on these data we aim to test whether the calculated activity concentration allows prediction of treatment results and side effects. For validation of the estimations in patients, socalled phantom-measurements with patient-like models will be performed.
The diagnosis and the decision for an appropriate treatment of a given patient will be independent of the SPECT/CT quantification results. Thus, the included patients in this study will experience neither advantages nor disadvantages.

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

Brief Summary in Scientific Language

Scientific Short version
While quantitative parameters like the SUV (standardized uptake value) are more and more used in PET/CT to improve interpretation of imaging results, an exact quantification was not possible in the SPECT/CT until recently. Newest SPECT/CT cameras are now able to quantify radiotracer concentration similar to PET/CT. This is made possible by correction of emission data for imaging properties of the detector and for attenuation using the inbuilt CT. The SPECT/CT-camera GE Healthcare Discovery 670 PRO® established at the Department of Nuclear Medicine and Clinical Molecular Imaging in October 2014 is the first worldwide installation of a commercially available SPECT/CT quantification system. In this study the acquired data of clinical SPECT/CT examinations will be used for a first application of quantification. In addition, simulations will be performed with different phantom-experiments to validate quantification in organs, tumors and other regions of interest.
The decision for SPECT/CT in patients will exclusively be made as clinically appropriate with regard to the issues transferred by referring physician. Since the clinical benefit of SPECT/CT quantification has not yet been established, clinical reports will still be based on non-quantitative and semi quantitative data.
Only clinical indicated diagnostic scintigraphy will be performed as part of this prospective data acquisition. No study specific examinations will be done.
The patients will be recruited at the Department of Nuclear Medicine and Clinical Molecular Imaging. Study data acquisition is planned over a period of 3 years.


Aims of the study:
• Correlation of the radiotracer accumulation with manifestation of the disease in patients treated at the Department of Nuclearmedicine (i.g. SIRT in liver tumors, radionuclide therapy of osseous metastases in prostate cancer). In addition correlations with outcome of therapy and potential side effects will be investigated.
• Influence of segmentation parameters of (CT-information, NM-image, Threshholds) on measured activity and distribution volume
• Comparison of the results of phantom measurements in variation of Target-Background-ratio, lesion size and simulated tissue attenuation
• Comparison with established semiquantitative analyses of the tracer uptake (i.g. Shunt assessment in SIRT simulation)

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

Organizational Data

  •   DRKS00013571
  •   2018/02/19
  •   [---]*
  •   yes
  •   Approved
  •   747/2014/BO1, Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   C61 -  Malignant neoplasm of prostate
  •   C78.7 -  Secondary malignant neoplasm of liver and intrahepatic bile duct
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Single-arm observational study: In this study the image datasets from clinical SPECT/CT examinations of patients will additionallly be revised with the new quantification methods. Thus, the concentration of the radiopharmacon in various body areas will be calculated exactly.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Diagnostic
  •   Other
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Overall Survival over a period of 3 years
Aims of the study:
• Correlation of the radiotracer accumulation with manifestation of the disease in patients treated at the Department of Nuclearmedicine (i.g. SIRT in liver tumors, radionuclide therapy of osseous metastases in prostate cancer). In addition correlations with outcome of therapy and potential side effects will be investigated.
• Influence of segmentation parameters of (CT-information, NM-image, Threshholds) on measured activity and distribution volume
• Comparison of the results of phantom measurements in variation of Target-Background-ratio, lesion size and simulated tissue attenuation
• Comparison with established semiquantitative analyses of the tracer uptake (i.g. Shunt assessment in SIRT simulation)

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

Secondary Outcome

Progression-free survival over a period of 3 years

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
  •   2015/04/22
  •   500
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

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

Additional Inclusion Criteria

indication for SPECT/CT examination

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

Exclusion Criteria

pregnancy

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

Addresses

end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

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