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.)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00609843

Enrollment

Registered

2008-02-07

Start date

2008-02-29

Completion date

2009-04-30

Last updated

2015-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer

Keywords

Bladder cancer, Radiotherapy, Tumour delineation, Markers

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.

Detailed 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.

Interventions

OTHERLipiodol 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026