C61
Conditions
Interventions
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
Sponsors
Universitätsklinik für Urologie, Klinikum Oldenburg, Fakultät für Medizin und Gesundheitswissenschaften, Carl von Ossietzky Universität Oldenburg
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: intermediate or high risk Prostate cancer: PSA greater than 10 and/or Gleason score graeter or equal to 7
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Germany
Contacts
Public ContactAlexander Winter
Universitätsklinik für Urologie, Klinikum Oldenburg, Fakultät für Medizin und Gesundheitswissenschaften, Carl von Ossietzky Universität Oldenburg
Outcome results
None listed