lymph node metastases Prostate cancer
Conditions
Interventions
Patients will receive a pre-operative and post-operative MRI-scan and a
pre-operative magnetic tracer injection around the tumour.
Sponsors
Universitieit Twente
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Adults 18 years and older with a >=cT1N0M0 cinically significant prostate tumour classification and who are scheduled for a prostatectomy
Exclusion criteria
Exclusion criteria: Contra-indications for robot assisted laparoscopy, intolerance/hypersensitivity to iron or dextran compounds or Magtrace®, patients with an iron overload disease, patients with pacemakers or other implantable devices in the chest wall and/or lower body. Also prostate cancer patients without excessable rectum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| There are two main study parameters: (1) identification of LNs with magnetic particles based on the pre-operative Sentimag inspection and MRI-scan and (2) pathological research of all dissected lymph nodes to correlate if lymph nodes with metastases also contain magnetic particles. | — |
Secondary
| Measure | Time frame |
|---|---|
| There are several secondary study parameters. The main secondary study parameter is the identification of LNs containing magnetic particles with the DiffMag detector, and to compare this with the Sentimag® detector, thus proving the feasibility of the new prototype detector. Both detectors will also be compared with the pathological results (do detected LNs also contain magnetic tracer). To summarize we register the following secondary parameters: - Proportion of LNs where the magnetic tracer could be detected with the DiffMag detector (detection rate DiffMag detector), of all dissected LNs - Proportion of LNs where the magnetic tracer could be detected with the Sentimag® detector (detection rate Sentimag® detector), of all dissected LNs - False positive rate for both detectors (detector measures magnetic tracer, but none is pathological found) - False negative rate for both detectors (detector does not measure magnetic tracer, but is pathological found) Additional secondary study parameters: - Total amount of injected SPIONs - Exact time between injection and operation - Proportion of LN which could still be visualized on the post-operative MRI (missed LNs) - Total operating time Other registered parameters: - Age - Sex - Height/weight (BMI) - Use of medicine - Type, location and size of cancer | — |
Countries
Netherlands
Outcome results
None listed