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. Identifier: NCT00609843
Recruitment Status : Completed
First Posted : February 7, 2008
Last Update Posted : December 7, 2015
The Oncology department of Aarhus Sygehus, Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus

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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Other: Lipiodol demarcation of the bladder tumour Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (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.)
Study Start Date : February 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Experimental: 1 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.

Primary Outcome Measures :
  1. Is Lipiodol demarcation visible on the planning CT (Feasibility) [ Time Frame: Before Radiotherapy ]
  2. Is Lipiodol visible on CBCT during Radiotherapy treatment (duration) [ Time Frame: Daily the first week, then two times a week during Radiotherapy ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00609843

The Oncology department of Aarhus Sygehus, Aarhus University Hospital
Aarhus, Region Midtjylland, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
The Oncology department of Aarhus Sygehus, Aarhus University Hospital
Principal Investigator: Jimmi Søndergaard, M.D The Oncologic department of Aarhus Sygehus, Aarhus University Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Aarhus Identifier: NCT00609843     History of Changes
Other Study ID Numbers: PilotBladder-IGRT
First Posted: February 7, 2008    Key Record Dates
Last Update Posted: December 7, 2015
Last Verified: July 2009

Keywords provided by University of Aarhus:
Bladder cancer
Tumour delineation

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Ethiodized Oil
Antineoplastic Agents