Pilot Studie of Lipiodol Demarcation of the Tumour in Bladder Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.)

Conditions
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Bladder Cancer

Intervention / Treatment
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* Other: Lipiodol demarcation of the bladder tumour


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed primary muscle invasive transitional cell carcinoma of the Bladder. T1-4a, N0-1, M0. Non-operable or refuse operation. Eligible for curative Radiotherapy. Oral and written informed consent. Fertile women must have a negative pregnancy test before inclusion or use contraceptive pills or intrauterine device. Ongoing beta blocker treatment is paused before Lipiodol injection. Exclusion Criteria: Known metabolic disorder (hyperthyroidism, goiter) Allergy towards iodine. Pregnancy / breast-feeding Performance status ECOG > 2

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Other: Lipiodol demarcation of the bladder tumour<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Is Lipiodol demarcation visible on the planning CT (Feasibility) |  | Before Radiotherapy | 
| Is Lipiodol visible on CBCT during Radiotherapy treatment (duration) |  | Daily the first week, then two times a week during Radiotherapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bladder cancer, Radiotherapy, Tumour delineation, Markers