This is a pilotstudy after characterising prostate tissue by using DCE-MRI in patients with a localised prostate cancer.The relation between DCE-MRI and vasculature and oxygenation will be investigated as a preparation for further studies.
ID
Source
Brief title
Condition
- Reproductive neoplasms male malignant and unspecified
- Genitourinary tract disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The interpretation of the DCE-MRI will be in terms of vasculature, microvessel
density and the amount of vessel leakage.
The first question is whether this interpretation has it's basis in histology.
Secondary outcome
The second question is whtether these histologic characterisations can be
correlated with the presence of tumour and it's oxygenation.
Background summary
Dynamic contrast enhanced (DCE-) MRI improves the sensitivity ans specificity
of the detection of prostate cancer.
Next to the detection of tumour DCE-MRI also is able to produce
parameters which can describe vasculature, leakage and micro-vessel density.
Therefore DCE-MRI probably has a major role in characterising tissue.
Cell-differentiation (gleason-score), hypoxia and cell density are
prognostically relevant because they might help to differentiate in therapy,
like optimising the dose distribution in radiotherapy.
Up to now no studies have been described in characterising prostate
tisse by DCE-MRI.
Study objective
This is a pilotstudy after characterising prostate tissue by using DCE-MRI in
patients with a localised prostate cancer.
The relation between DCE-MRI and vasculature and oxygenation will be
investigated as a preparation for further studies.
Study design
Patients who will receive a prostatectomy will receive one 3.0 T MRI (including
a DCE measurement).
Next, histology will be evaluated by the pathologist and results will be
quantified.
Study burden and risks
Prior to the prostatectomy an MRI will be made, combined with a bladder
catheter and gadolineum contrast intraveniously injected. This is expected to
take 45 minutes.
At least two hours before surgery pimonidazole will be administered,
Risks:
§ Gadolineum: this has no known complications.
§ Bladder catheter: infectious cystitus, urethra trauma.
Heidelberglaan 100
3584 CX Utrecht
Nederland
Heidelberglaan 100
3584 CX Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
Patients who will receive a prostatectomy as treatment for a locallised prostate cancer
Exclusion criteria
No contraindications for a 3.0 T MRI
Design
Recruitment
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 | NL16190.041.07 |