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| Sponsors and Collaborators: |
University of Aarhus The Oncology department of Aarhus Sygehus, Aarhus University Hospital |
|---|---|
| Information provided by: | University of Aarhus |
| ClinicalTrials.gov Identifier: | NCT00609843 |
Purpose
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 | Intervention |
|---|---|
|
Bladder Cancer |
Other: Lipiodol demarcation of the bladder tumour |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Open Label, Single Group Assignment |
| 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.) |
| Estimated Enrollment: | 5 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | November 2008 |
| Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
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.
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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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Jimmi Søndergaard, M.D | +4589492651 | jimmi@oncology.dk |
| Denmark, Region Midtjylland | |
| The Oncology department of Aarhus Sygehus, Aarhus University Hospital | Recruiting |
| Aarhus, Region Midtjylland, Denmark, 8000 | |
| Principal Investigator: | Jimmi Søndergaard, M.D | The Oncologic department of Aarhus Sygehus, Aarhus University Hospital |
More Information
| Responsible Party: | The Oncology department of Aarhus Sygehus, Aarhus University Hospital ( Jimmi Søndergaard M.D ) |
| Study ID Numbers: | PilotBladder-IGRT |
| Study First Received: | January 24, 2008 |
| Last Updated: | July 8, 2008 |
| ClinicalTrials.gov Identifier: | NCT00609843 |
| Health Authority: | Denmark: Danish Dataprotection Agency; Denmark: Danish Medicines Agency; Denmark: The Danish National Committee on Biomedical Research Ethics |
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Bladder cancer Radiotherapy Tumour delineation Markers |
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Cystocele Urologic Diseases Ethiodized Oil Urinary Bladder Diseases Urinary Bladder Neoplasms |
Iodine Urogenital Neoplasms Urologic Neoplasms Urinary tract neoplasm Bladder neoplasm |
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Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
