Pilot Studie of Lipiodol Demarcation of the Tumour in Bladder Cancer
Rationale: Bladder tumours are often not visible on X-ray based image-modalities during planning and treatment of Radiotherapy.
Purpose: To determine if a single contrast (Lipiodol) demarcation of the bladder tumour before treatment is feasible and visible on multiple X-ray based image-modalities during Radiotherapy.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Lipiodol Demarcation of the Bladder Tumour in Adaptive Image-Guided Radiotherapy: A Pilot Study. (Danish: Lipiodol Til Markering af blæretumoren i Forbindelse Med Adaptiv Billedvejledt strålebehandling: Et Pilotstudie.)|
- Is Lipiodol demarcation visible on the planning CT (Feasibility) [ Time Frame: Before Radiotherapy ] [ Designated as safety issue: No ]
- Is Lipiodol visible on CBCT during Radiotherapy treatment (duration) [ Time Frame: Daily the first week, then two times a week during Radiotherapy ] [ Designated as safety issue: No ]
|Study Start Date:||February 2008|
|Study Completion Date:||April 2009|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
Other: Lipiodol demarcation of the bladder tumour
1-3 drops of Lipiodol Ultra Fluid (iodine 38%W/W) will be injected into the submucosa on 4 locations around the bladder tumour. The procedure is done once during a planned cystoscopy approximately a week before the planning CT.
To exploit the potential of modern Radiotherapy (RT), it is important to localize and follow the target precisely during treatment. Since the bladder tumour can usually not be identified on conventional CT-scan, a fiducial or contrast marking system is warranted.
The iodized oil, Lipiodol is a well-known contrast media used mainly for lymphography and Hysterosalpingography. Local Lipiodol demarcation has been used for localisation of tumours in the lung, prostate and seminal vesicles visualised on Computed Tomography (CT) and fluoroscopy.
Purpose: To evaluate the feasibility of tumour demarcation using the contrast agent Lipiodol in adaptive Image-guided RT of bladder cancer. Visibility on CT, Cone-Beam CT, MRI and on-board imaging will be evaluated.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00609843
|The Oncology department of Aarhus Sygehus, Aarhus University Hospital|
|Aarhus, Region Midtjylland, Denmark, 8000|
|Principal Investigator:||Jimmi Søndergaard, M.D||The Oncologic department of Aarhus Sygehus, Aarhus University Hospital|