Clinical trial NCT00609843: Pilot Studie of Lipiodol Demarcation of the Tumour in Bladder Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Cancer
Keywords: Bladder cancer
Radiotherapy
Tumour delineation
Markers
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2008-02-07
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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 criteria: 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

Primary outcomes:
measure: Is Lipiodol demarcation visible on the planning CT (Feasibility)
timeFrame: Before Radiotherapy
measure: Is Lipiodol visible on CBCT during Radiotherapy treatment (duration)
timeFrame: Daily the first week, then two times a week during Radiotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: The Oncology department of Aarhus Sygehus, Aarhus University Hospital
state: Region Midtjylland
Study officials:
affiliation: The Oncologic department of Aarhus Sygehus, Aarhus University Hospital
name: Jimmi Søndergaard, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sondergaard J, Olsen KO, Muren LP, Elstrom UV, Grau C, Hoyer M. A study of image-guided radiotherapy of bladder cancer based on lipiodol injection in the bladder wall. Acta Oncol. 2010 Oct;49(7):1109-15. doi: 10.3109/02841861003789491.