Pilot Studie of Lipiodol Demarcation of the Tumour in Bladder Cancer
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.)
1 other identifier
interventional
5
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 24, 2008
CompletedStudy Start
First participant enrolled
February 1, 2008
CompletedFirst Posted
Study publicly available on registry
February 7, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedDecember 7, 2015
July 1, 2009
1.2 years
January 24, 2008
December 4, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Is Lipiodol demarcation visible on the planning CT (Feasibility)
Before Radiotherapy
Is Lipiodol visible on CBCT during Radiotherapy treatment (duration)
Daily the first week, then two times a week during Radiotherapy
Study Arms (1)
1
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
- Ongoing beta blocker treatment is paused before Lipiodol injection.
You may not qualify if:
- Known metabolic disorder (hyperthyroidism, goiter)
- Allergy towards iodine.
- Pregnancy / breast-feeding
- Performance status ECOG \> 2
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aarhuslead
- Aarhus University Hospitalcollaborator
Study Sites (1)
The Oncology department of Aarhus Sygehus, Aarhus University Hospital
Aarhus, Central Jutland, 8000, Denmark
Related Publications (1)
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.
PMID: 20429726DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jimmi Søndergaard, M.D
The Oncologic department of Aarhus Sygehus, Aarhus University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2008
First Posted
February 7, 2008
Study Start
February 1, 2008
Primary Completion
April 1, 2009
Study Completion
April 1, 2009
Last Updated
December 7, 2015
Record last verified: 2009-07