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Completed

NCT Number: NCT00609843

Pilot Studie of Lipiodol Demarcation of the Tumour in Bladder Cancer

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.

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Key information

Conditions

Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Oncology department of Aarhus Sygehus, Aarhus University Hospital

Aarhus, Central Jutland, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lipiodol demarcation of the bladder tumour

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.

Primary outcomes

  1. Is Lipiodol demarcation visible on the planning CT (Feasibility)

    Time frame: Before Radiotherapy

  2. Is Lipiodol visible on CBCT during Radiotherapy treatment (duration)

    Time frame: Daily the first week, then two times a week during Radiotherapy

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital

Registry information

Official study 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.)

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 7, 2008
Registry last updated
Dec 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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