Image-Guided Tumorboost of Bladder Cancer
Conditions
Bladder Neoplasms
Conditions: official terms
Urinary Bladder Neoplasms
Conditions: Keywords
Image-guided Radiotherapy, Fiducial marker, Adverse effects
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Radiation boost
Type: Radiation
Overall Status
Recruiting
Summary
The purpose of the study is to increase the radiation dose (Boost) to the bladder tumor. The bladder cancer patients included in the study will undergo tumor demarcation. The bladder demarcations will then be the target for an image-guided boost delivered precisely to the expected tumor site.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Muscle invasive bladder cancer (transitional carcinoma)

- Unifocal

- TNM stage T2a-4a, N0-1, M0

- unfit for radical cystectomy

Exclusion Criteria:

- Hyperthyroidism

- Multinodular goiter

- Pregnancy

- Breast feeding

- WHO preformance status more than 2

- Iodine allergy

- MRI or CT contrast media allergy

- Bi-lateral hip-prosthesis
Locations
The department of Oncology, Aarhus University Hospital
Aarhus, Denmark
Status: Recruiting
Contact: Jimmi Sondergaard - jimmsoen@rm.dk
The department of Oncology, Rigshospitalet
Copenhagen, Denmark
Status: Not yet recruiting
Contact: Peter M Petersen - peter.meidahl.petersen@rh.regionh.dk
The department of Oncology, Herlev University Hospital
Herlev, Denmark
Status: Recruiting
Contact: Lisa Sengelov - LISE@heh.regionh.dk
The department of Oncology, Odense University Hospital
Odense, Denmark
Status: Not yet recruiting
Contact: Niels V Jensen - Niels.Viggo.Jensen@ouh.regionsyddanmark.dk
Start Date
August 2009
Completion Date
January 2017
Sponsors
University of Aarhus
Source
University of Aarhus
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page