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Pilot Studie of Lipiodol Demarcation of the Tumour in Bladder Cancer

This study has been completed.
Sponsor:
Collaborator:
The Oncology department of Aarhus Sygehus, Aarhus University Hospital
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00609843
First received: January 24, 2008
Last updated: July 10, 2009
Last verified: July 2009
History of Changes
  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: Intervention Model: Single Group Assignment
Masking: 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.)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Is Lipiodol demarcation visible on the planning CT (Feasibility) [ Time Frame: Before Radiotherapy ] [ Designated as safety issue: No ]
  • Is Lipiodol visible on CBCT during Radiotherapy treatment (duration) [ Time Frame: Daily the first week, then two times a week during Radiotherapy ] [ Designated as safety issue: No ]

Estimated Enrollment: 5
Study Start Date: February 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00609843

Locations
Denmark
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
Investigators
Principal Investigator: Jimmi Søndergaard, M.D The Oncologic department of Aarhus Sygehus, Aarhus University Hospital
  More Information

No publications provided by University of Aarhus

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jimmi Søndergaard M.D, The Oncology department of Aarhus Sygehus, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT00609843     History of Changes
Other Study ID Numbers: PilotBladder-IGRT
Study First Received: January 24, 2008
Last Updated: July 10, 2009
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Bladder cancer
Radiotherapy
Tumour delineation
Markers

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

ClinicalTrials.gov processed this record on June 18, 2013