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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.)


N/A
18 Years
N/A
Not Enrolling
Both
Bladder Cancer

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Trial Information

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.)


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Is Lipiodol demarcation visible on the planning CT (Feasibility)

Outcome Time Frame:

Before Radiotherapy

Safety Issue:

No

Principal Investigator

Jimmi Søndergaard, M.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Oncologic department of Aarhus Sygehus, Aarhus University Hospital

Authority:

Denmark: Danish Dataprotection Agency

Study ID:

PilotBladder-IGRT

NCT ID:

NCT00609843

Start Date:

February 2008

Completion Date:

April 2009

Related Keywords:

  • Bladder Cancer
  • Bladder cancer
  • Radiotherapy
  • Tumour delineation
  • Markers
  • Urinary Bladder Neoplasms

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