Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006485

Trial Description

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Title

Detection of Lymph Nodes by Means of Intraoperative Fluorescence Lymphography Using Indocyanine Green (ICG) During the Radical Robot-assisted Prostatectomy

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The purpose of this study is to investigate, whether the detection of lymph nodes by means
of intraoperative fluorescence lymphography as part of lymphadenectomy in robot-assisted
radical prostatectomy is higher than without the use of indocyanine green (ICG).

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Brief Summary in Scientific Language

ICG is a fluorescent dye that fluoresces green bound to proteins under illumination in the
near-infrared range. Using this dye allows to visualize lymphatic nodes, by being injected
into the tumor or directly surrounding tissue.

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Organizational Data

  •   DRKS00006485
  •   2015/03/23
  •   2014/06/10
  •   yes
  •   [---]*
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Secondary IDs

  •   U1111-1157-6624 
  •   NCT02163083  (ClinicalTrials.gov)
  •   U1111-1157-6624  (St. Antonius Hospital Gronau)
  •   2013-609-f-S 
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Health Condition or Problem studied

  •   Prostate Cancer
  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   Procedure: ICG
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Prevention
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

- The total number of detection rate of (positive) lymph nodes using ICG; time frame: during the surgery

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Secondary Outcome

- Measurements of the time, that takes to remove the lymph nodes; time frame: During the surgery

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

  •   [---]*
  •   2014/07/31
  •   120
  •   [---]*
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Inclusion Criteria

  •   Male
  •   18   Years
  •   75   Years
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Additional Inclusion Criteria

- Histologically confirmed locally limited prostate cancer;

- Intermediate or high risk tumor

- Recommended and planned prostatectomy;

- Completed and signed written consent;

- Voluntarily agreement to participate in this study

- Age of the study participants ≥ 18 years.

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Exclusion Criteria

- Allergic reaction to active ingredient (indocyanine green);

- Iodine allergy;

- Hyperthyroidism;

- High-grade renal impairment;

- High-grade hepatic insufficiency;

- Unwillingness to the storage and disclosure of pseudonymous disease and personal data

- psychiatric pre-existing conditions or other circumstances that make a cooperation by
the patient in question

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Addresses

  • start of 1:1-Block address primary-sponsor
    • St. Antonius Hospital Gronau
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    •   [---]*
    •   [---]*
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    • St. Antonius Hospital Gronau
    • Jörn H. Witt, MD 
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    •   [---]*
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    •   [---]*
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    • St. Antonius Hospital Gronau
    • Jörn H. Witt, MD 
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    start of 1:1-Block address contact public-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
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Trial Publications, Results and other Documents

  • [---]*
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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   4
  •   2016/01/14


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