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Image-Guided Tumorboost of Bladder Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00963404
Recruitment Status : Completed
First Posted : August 21, 2009
Last Update Posted : May 3, 2018
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus

Brief 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.

Condition or disease Intervention/treatment Phase
Bladder Neoplasms Radiation: Radiation boost Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Image-guided Tumorboost of Localized Unifocal Bladder Cancer: A Phase I/II Study
Study Start Date : August 2009
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Experimental: Tumor-boost
Image-guided tumorboost of the bladder cancer.
Radiation: Radiation boost
Radiation boost of the bladder-tumor: 10 Gy/5 fractions, 2 Gy per fraction.

Primary Outcome Measures :
  1. Local tumor control [ Time Frame: One year ]

Secondary Outcome Measures :
  1. Acute and late adverse effects of the radiotherapy treatment [ Time Frame: 3 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00963404

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The department of Oncology, Aarhus University Hospital
Aarhus, Denmark, Dk-8000
The department of Oncology, Rigshospitalet
Copenhagen, Denmark, Dk-2100
The department of Oncology, Herlev University Hospital
Herlev, Denmark, Dk-2730
The department of Oncology, Odense University Hospital
Odense, Denmark, Dk-5000
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
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Principal Investigator: Jimmi Sondergaard The department of Oncology, Aarhus University Hospital
Additional Information:
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Responsible Party: University of Aarhus Identifier: NCT00963404    
Other Study ID Numbers: CIRRO IP 070109 DaBlaCa-1
First Posted: August 21, 2009    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: January 2018
Keywords provided by University of Aarhus:
Image-guided Radiotherapy
Fiducial marker
Adverse effects
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases