Pilot Studie of Lipiodol Demarcation of the Tumour in Bladder Cancer
Primary Purpose
Bladder Cancer
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Lipiodol demarcation of the bladder tumour
Sponsored by
About this trial
This is an interventional diagnostic trial for Bladder Cancer focused on measuring Bladder cancer, Radiotherapy, Tumour delineation, Markers
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
Sites / Locations
- The Oncology department of Aarhus Sygehus, Aarhus University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Is Lipiodol demarcation visible on the planning CT (Feasibility)
Is Lipiodol visible on CBCT during Radiotherapy treatment (duration)
Secondary Outcome Measures
Full Information
NCT ID
NCT00609843
First Posted
January 24, 2008
Last Updated
December 4, 2015
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00609843
Brief Title
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
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
Bladder cancer, Radiotherapy, Tumour delineation, Markers
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Lipiodol demarcation of the bladder tumour
Intervention Description
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 Measure Information:
Title
Is Lipiodol demarcation visible on the planning CT (Feasibility)
Time Frame
Before Radiotherapy
Title
Is Lipiodol visible on CBCT during Radiotherapy treatment (duration)
Time Frame
Daily the first week, then two times a week during Radiotherapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jimmi Søndergaard, M.D
Organizational Affiliation
The Oncologic department of Aarhus Sygehus, Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Oncology department of Aarhus Sygehus, Aarhus University Hospital
City
Aarhus
State/Province
Region Midtjylland
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
20429726
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.
Results Reference
derived
Learn more about this trial
Pilot Studie of Lipiodol Demarcation of the Tumour in Bladder Cancer
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