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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00007671 |
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Date of registration:
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09/01/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Magnetometer guided sentinel lymphadenectomy after marking with superparamagnetic iron oxide nanoparticles versus extended lymphadenectomy in prostate cancer: rate of detection and sensitivity in comparison
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Scientific title:
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Magnetometer guided sentinel lymphadenectomy after marking with superparamagnetic iron oxide nanoparticles versus extended lymphadenectomy in prostate cancer: rate of detection and sensitivity in comparison - SentiMagPro II |
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Date of first enrolment:
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24/02/2015 |
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Target sample size:
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50 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00007671 |
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Study type:
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interventional |
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Study design:
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Allocation: N/A: single arm study; Masking: Open (masking not used); Control: uncontrolled; Assignment: single; Study design purpose: diagnostic
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Phase:
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N/A
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Countries of recruitment
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Germany
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Contacts
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Name:
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Alexander
Winter |
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Address:
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Rahel-Straus-Str. 10
26133
Oldenburg
Germany |
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Telephone:
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04414032302 |
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Email:
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winter.alexander@klinikum-oldenburg.de |
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Affiliation:
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Universitätsklinik für Urologie, Klinikum Oldenburg, Fakultät für Medizin und Gesundheitswissenschaften, Carl von Ossietzky Universität Oldenburg |
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Name:
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Alexander
Winter |
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Address:
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Rahel-Straus-Str. 10
26133
Oldenburg
Germany |
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Telephone:
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04414032302 |
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Email:
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winter.alexander@klinikum-oldenburg.de |
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Affiliation:
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Universitätsklinik für Urologie, Klinikum Oldenburg, Fakultät für Medizin und Gesundheitswissenschaften, Carl von Ossietzky Universität Oldenburg |
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Key inclusion & exclusion criteria
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Inclusion criteria: intermediate or high risk Prostate cancer: PSA greater than 10 and/or Gleason score graeter or equal to 7
Exclusion criteria: Intolerance / hypersensitivity to iron or dextran or Sienna +, patients with iron overload disease, cardiac pacemakers or other in the chest wall implanted devices, patients with hip prostheses or other metallic implants in the pelvic area, patients with previous surgery on the prostate (eg transurethral prostate resection, adenomectomy, laser enucleation); patient, who are not capable of giving consent
Age minimum:
18 Years
Age maximum:
None
Gender:
Male
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Health Condition(s) or Problem(s) studied
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C61
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Malignant neoplasm of prostate
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Intervention(s)
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Group 1: transrectally injection of superparamagnetic iron oxid nanoparticles (Sienna+, 2 ml) into the prostate using ultrasound guidence 1 day before surgery; magnetometer guided sentinel lymph node dissection and extended lymphadenectomy in combination with a radical retropubic prostatectomy
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Primary Outcome(s)
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Intraoperative detection rate of sentinel lymph nodes:
number of patients with at least one intraoperative sentinel lymph node detected by magnetometer (SentiMag) guidence / number of operated patients in total
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Secondary Outcome(s)
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Sensitivity of the SentiMag method in detection of lymph node metastases:
- based on patients: number of patients with positive sentinel lymph nodes / total number of patients with positive lymph nodes
- based on lymph nodes:
number of positive sentinel lymph nodes / total number of positive lymph nodes
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Source(s) of Monetary Support
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Carl von Ossietzky Universität Oldenburg
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Ethics review
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Status: Approved
Approval date: 08/09/2014
Contact:
ethikkommission@aekn.de
Ethikkommission bei der Ärztekammer Niedersachsen, Unterkommission zur Beurteilung medizinischer Forschung am Menschen
+49-511-3802208
ethikkommission@aekn.de
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