The primary goal is to increase the available information for the surgeon by providing an extensive lymph node map of the patient. The secondary goal is to compare two magnetic detectors for the further development of a laparoscopic version. The…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
Background summary
Patients diagnosed with a prostate tumour but without visible metastases on
imaging modalities can still have small metastases in the local lymph nodes. To
discover and possibly treat this the tumour and (on indication) all surrounding
lymph nodes are surgically removed. However, in 54-96% of the prostate cancer
patients no metastases were found in the resected pelvic lymph nodes. Also in
26-56% of patients tumour draining lymph nodes lie outside the usual resection
area. For this reason the first step to improve this procedure should be to
increase the available information by performing extensive lymph node mapping.
For mapping lymph nodes a radioactive tracer is currently used as gold standard
in breast cancer patients. The radioactive tracer has four known disadvantages;
(1) limited availability, (2) strict rules and regulations, (3) degradation
time and (4) radioactive load for user and patient. Another option is using a
magnetic tracer such as Magtrace®. This tracer can be found intraoperative
through a magnetic detector and beforehand through an MRI-scan.
Study objective
The primary goal is to increase the available information for the surgeon by
providing an extensive lymph node map of the patient. The secondary goal is to
compare two magnetic detectors for the further development of a laparoscopic
version. The final studygoal is to develop a laparoscopic sentinel node
procedure for prostate cancer patients.
Study design
This is a prospective, interventional, single centre pilot trial, with the main
goal to increase the available information made to maximize outcome. Also a
comparison between a CE approved first generation magnetic detector (the
Sentimag®) with a new prototype second generation magnetic detector (the
DiffMag) in an ex vivo study setup will be done for the further development of
a laparoscopic magnetic detector.
Intervention
Patients will receive a pre-operative and post-operative MRI-scan and a
pre-operative magnetic tracer injection around the tumour.
Study burden and risks
Burden: Additional local interstitial injections with magnetic tracer.
Additional Sentimag® inspection pre-operative. Additional magnetic resonance
imaging pre-operative and post-operative.
Risks & benefits: It could very well be that the current resection area is not
adequate. This research will verify this and can be used as input for further
research to optimise prostate cancer treatment.
Drienerlolaan 5
Enschede 7522 NB
NL
Drienerlolaan 5
Enschede 7522 NB
NL
Listed location countries
Age
Inclusion criteria
Adults 18 years and older with a >=cT1N0M0 cinically significant prostate tumour
classification and who are scheduled for a prostatectomy
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL67624.091.19 |