Pilot Studie of Lipiodol Demarcation of the Tumour in Bladder Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00609843|
Recruitment Status : Completed
First Posted : February 7, 2008
Last Update Posted : December 7, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer||Other: Lipiodol demarcation of the bladder tumour||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.)|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||April 2009|
|Actual Study Completion Date :||April 2009|
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.
- Is Lipiodol demarcation visible on the planning CT (Feasibility) [ Time Frame: Before Radiotherapy ]
- Is Lipiodol visible on CBCT during Radiotherapy treatment (duration) [ Time Frame: Daily the first week, then two times a week during Radiotherapy ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|