Pilot Studie of Lipiodol Demarcation of the Tumour in Bladder Cancer

Bladder Cancer Clinical Trial

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.)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00609843
• Other study ID #: PilotBladder-IGRT
• Status: Completed
• Phase: N/A
• First received: January 24, 2008
• Last updated: December 4, 2015
• Start date: February 2008
• Est. completion date: April 2009

Study information

• Verified date: July 2009
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Danish Medicines AgencyDenmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Denmark	The Oncology department of Aarhus Sygehus, Aarhus University Hospital	Aarhus	Region Midtjylland

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	The Oncology department of Aarhus Sygehus, Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Is Lipiodol demarcation visible on the planning CT (Feasibility)		Before Radiotherapy	No
Primary	Is Lipiodol visible on CBCT during Radiotherapy treatment (duration)		Daily the first week, then two times a week during Radiotherapy	No