This study aims to evaluate different techniques for emptying, flushing and filling of the bladder using a bladder catheter in a pilot study, to find and standardise the best technique. This will make FDG-PET/CT suitable for response monitoring of (…
ID
Source
Brief title
Condition
- Renal and urinary tract neoplasms malignant and unspecified
- Bladder and bladder neck disorders (excl calculi)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The best technique for visualisation and quantification of bladder cancer with
FDG-PET/CT, and standardisation thereof.
Secondary outcome
none.
Background summary
Primary bladder cancer cannot be visualised or quantified using FDG-PET/CT due
to the presence of excreted FDG in the bladder. Delayed imaging and forced
diuresis have insufficient effect. Flushing and filling of the bladder with a
bladder catheter has been described and is effective, but the procedure has
never been standardised. Differences in bladder volume and residual FDG after
flushing and filling hamper the measurements. Therefore, standardised
visualisation and quantification is not an option at this moment, and therefore
response evaluation of chemotherapie is not reliably possible.
Study objective
This study aims to evaluate different techniques for emptying, flushing and
filling of the bladder using a bladder catheter in a pilot study, to find and
standardise the best technique. This will make FDG-PET/CT suitable for response
monitoring of (neoadjuvant) chemotherapie for primary bladder cancer in future
patients.
Study design
Ten patients will undergo FDG-PET/CT while FDG containing urin is removed from
the bladder with a bladder catheter, using four different strategies for
flushing and filling. The technique that yields the best visualisation and the
most reliable quantification will be determined using visual evaluation and
standardised uptake value (SUV) measurements.
Study burden and risks
Limited risk of bladder catheter placement and one intravenous injection. The
radiation burden of one FDG-PET/CT scan is not considered a significant risk.
Plesmanlaan 121
1066 CX
Nederland
Plesmanlaan 121
1066 CX
Nederland
Listed location countries
Age
Inclusion criteria
1. Histology proven bladder cancer
2. Untreated, primary evaluation
3. cT2-4 Nx Mx
Exclusion criteria
1. Contra-indication for bladder catheter
2. Pregnancy or breastfeeding
3. Age < 18 years
4. Restricted water intake
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 | NL27877.031.09 |