Trial document




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  DRKS00010966

Trial Description

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Title

Pilot study for multiparametric characterization and evaluation of the movement of upper abdominal organs by 4D MRI

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Trial Acronym

PK4DMRT

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Due to breathing, filling of the stomach, intestinal movement and the pulsation of the large blood vessels move the liver or pancreas tumor and the nearby organs. In order to be able to irradiate the tumor sufficiently, relatively large positioning uncertainties have to be included in radiation treatment planning. Furthermore planning is currently only performed on the basis of computer tomography (CT). Unfortunately CT only shows a poor soft tissue contrast, which is especially crucial in the abdominal region
The goal of this pilot study is a multiparametric characterization of the pancreatic tumor and the imaging of the deformation of the liver- and pancreatic tumor as well as the surrounding organs with MRI. Further to the analysis of the deformation, its reduction is aimed at by the utilization of an abdominal corset. In future this should allow for a better treatment of patients with pancreatic cancer. (date of amendment 2: 02/01/ 2018, changed parameter: additional inclusion of patients with a primary hepatocellular carcinoma or with few liver metastases of a solid tumor with indication for radiotherapy)

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Brief Summary in Scientific Language

In this pilot study an MRI protocol optimized for the abdominal imaging shall be verified as such, in order to allow for a better multiparametric characterization of the primary pancreatic carcinoma as well as for the evaluation of the non-rigid deformation of pancreatic carcinoma and hepatocellular carcinoma or liver metastases as well as surrounding upper abdominal organs. By quantifying the deformation of tumor and organs (due to respiration, pulsation, organ filling) and implementing this information in the radiation treatment planning (photons, protons) of pancreatic carcinoma, a higher local tumor control and a reduction in toxicity through radio(chemo)therapy of pancreatic or liver carcinoma or unresectable liver metastases shall be achieved in future prospective studies.

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Organizational Data

  •   DRKS00010966
  •   2016/11/07
  •   [---]*
  •   yes
  •   Approved
  •   EK398092016, Ethikkommission der Medizinischen Fakultät der Technischen Universität Dresden
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Secondary IDs

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Health Condition or Problem studied

  •   C25 -  Malignant neoplasm of pancreas
  •   Primary hepatocellular carcinoma
    1-2 liver metastases
  •   C22.0 -  Malignant neoplasm: Liver cell carcinoma
  •   C78.7 -  Secondary malignant neoplasm of liver and intrahepatic bile duct
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Interventions/Observational Groups

  •   Examination of 10 patients with adenocarcinoma of the pancreas head, primary hepatocellular carcinoma or 1-2 liver metastases using a MRI protocol (ScanTime <30 min) optimized for the abdominal imaging, both with and without an individual abdominal corset.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Multiparametric characterization of the pancreatic carcinoma and the quantitative information of the non-rigid deformation of pancreatic- or liver tumor and organs at risk by 4D MRI.

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Secondary Outcome

Comparison of the deformation of the tumor and the surrounding organs at risk with and without the utilization of an abdominal corset as well as the evaluation of its acceptability from the patient’s perspective. Furthermore, the inter- and intra-individual difference of the non-rigid deformation shall be investigated, considering the tumor state (primarily resectable versus unresectable).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/10/23
  •   10
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- primary resectable or non-resectable adenocarcinoma of the pancreas without distant metastases (M0), with indication for (chemotherapy and following) surgical intervention
- primary hepatocellular carcinoma with indication for primary radiotherapy
- 1-2 liver metastases of a solid tumor with indication for radiotherapy
- Good general condition (ECOG performance status 0 or 1)
- written informed consent

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Exclusion Criteria

- neoadjuvant (radio) chemotherapy
- multiple intra-abdominal surgical interventions, which affect the organ movability
- Lack of consent of the patient to participate in the study or lack of cooperation with regard to the therapy or follow-up
- Contraindication to performing an MRI scan (for example, pacemakers, cochlear implants, garnet or other metal fragments, hip replacement, insulin pump, spiral (intrauterine pessary), not removable piercings, tattoos or "permanent make-up")
- Contraindication for administration of gadolinium contrast agents
- intense claustrophobia

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Addresses

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    • Universitätsklinikum Dresden, Klinik und Poliklinik für Strahlentherapie und Radioonkologie
    • Ms.  Prof.  Esther  Troost 
    • Fetscherstraße 74
    • 01307  Dresden
    • Germany
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    • Universitätsklinikum Dresden, Klinik und Poliklinik für Strahlentherapie und Radioonkologie
    • Ms.  Prof.  Esther  Troost 
    • Fetscherstraße 74
    • 01307  Dresden
    • Germany
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    • Universitätsklinikum Dresden, Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Klinisches Studienzentrum
    • Ms.  Annett  Klöber 
    • Fetscherstraße 74
    • 01307  Dresden
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Carl Gustav Carus
    • Fetscherstr. 74
    • 01307  Dresden
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.