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Pilot Studie of Lipiodol Demarcation of the Tumour in Bladder Cancer

Primary Purpose

Bladder Cancer

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Lipiodol demarcation of the bladder tumour

About this trial

This is an interventional diagnostic trial for Bladder Cancer focused on measuring Bladder cancer, Radiotherapy, Tumour delineation, Markers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

The Oncology department of Aarhus Sygehus, Aarhus University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Is Lipiodol demarcation visible on the planning CT (Feasibility)

Is Lipiodol visible on CBCT during Radiotherapy treatment (duration)

Secondary Outcome Measures

Full Information

NCT ID

NCT00609843

First Posted

January 24, 2008

Last Updated

December 4, 2015

Sponsor

University of Aarhus

Collaborators

Aarhus University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00609843

Brief Title

Pilot Studie of Lipiodol Demarcation of the Tumour in Bladder Cancer

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.)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2009

Overall Recruitment Status

Completed

Study Start Date

February 2008 (undefined)

Primary Completion Date

April 2009 (Actual)

Study Completion Date

April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Aarhus

Collaborators

Aarhus University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bladder Cancer

Keywords

Bladder cancer, Radiotherapy, Tumour delineation, Markers

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

Lipiodol demarcation of the bladder tumour

Intervention Description

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 Outcome Measure Information:

Title

Is Lipiodol demarcation visible on the planning CT (Feasibility)

Time Frame

Before Radiotherapy

Title

Is Lipiodol visible on CBCT during Radiotherapy treatment (duration)

Time Frame

Daily the first week, then two times a week during Radiotherapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jimmi Søndergaard, M.D

Organizational Affiliation

The Oncologic department of Aarhus Sygehus, Aarhus University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Oncology department of Aarhus Sygehus, Aarhus University Hospital

City

Aarhus

State/Province

Region Midtjylland

ZIP/Postal Code

8000

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

20429726

Citation

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.

Results Reference

derived

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Pilot Studie of Lipiodol Demarcation of the Tumour in Bladder Cancer

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