Pilot Studie of Lipiodol Demarcation of the Tumour in Bladder Cancer

December 4, 2015 updated by: University of Aarhus

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.)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Region Midtjylland
      • Aarhus, Region Midtjylland, Denmark, 8000
        • The Oncology department of Aarhus Sygehus, Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Aarhus University Hospital

Investigators

  • Principal Investigator: Jimmi Søndergaard, M.D, The Oncologic department of Aarhus Sygehus, Aarhus University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

January 24, 2008

First Submitted That Met QC Criteria

January 24, 2008

First Posted (Estimate)

February 7, 2008

Study Record Updates

Last Update Posted (Estimate)

December 7, 2015

Last Update Submitted That Met QC Criteria

December 4, 2015

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PilotBladder-IGRT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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