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Pilot Studie of Lipiodol Demarcation of the Tumour in Bladder Cancer

NCT ID: NCT00609843

Last Updated: 2015-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-04-30

Brief Summary

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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

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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.

Conditions

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Bladder Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Lipiodol demarcation of the bladder tumour

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jimmi Søndergaard, M.D

Role: PRINCIPAL_INVESTIGATOR

The Oncologic department of Aarhus Sygehus, Aarhus University Hospital

Locations

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The Oncology department of Aarhus Sygehus, Aarhus University Hospital

Aarhus, Central Jutland, Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 20429726 (View on PubMed)

Other Identifiers

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PilotBladder-IGRT

Identifier Type: -

Identifier Source: org_study_id