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Biological Imaging Guided Antalgic Radiotherapy of Bone Metastases (Phase II Trial)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by University Hospital, Ghent.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00503178
First received: July 17, 2007
Last updated: December 4, 2014
Last verified: December 2014
  Purpose
Highly selective irradiation requires accurate target definition by high-resolution three-dimensional imaging. Co-registration of FDG-PET and high-resolution CT might be the imaging modality of choice. This choice might target radiation therapy precisely to the intra-osseous volume that is responsible for pain and to spare selectively healthy bone in the vicinity of the metastasis. This strategy could result in equal anti-pain efficacy as conventional large volume radiotherapy, but could allow bone remodeling and preservation of bone structural strength in the vicinity and could lead to reduced toxicity to neighboring organs.

Condition Intervention Phase
Bone Metastases
Procedure: Biological imaging guided antalgic radiotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Biological Imaging Guided Antalgic Radiotherapy of Bone Metastases (Phase II Trial)

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Pain assessment [ Time Frame: t0 ]

Secondary Outcome Measures:
  • Acute toxicity [ Time Frame: t0 ]
  • Bone remodeling [ Time Frame: t0 ]
  • Resulting volumes of the targets and functional active areas [ Time Frame: t0 ]
  • Mismatch and/or overlap areas [ Time Frame: t0 ]

Estimated Enrollment: 20
Study Start Date: April 2006
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patients undergoing imaging guided radiotherapy. Procedure: Biological imaging guided antalgic radiotherapy
Biological imaging guided antalgic radiotherapy is followed.

  Eligibility

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Painful bone metastasis of solid tumors
  • A maximum number of bone metastases less or equal to 3
  • Life expectancy > 6 months
  • Minimum age 21 years
  • Signed informed consent

Exclusion Criteria:

  • Previous radiotherapy to the painful site
  • Bone metastasis from malignant melanoma or renal cell carcinoma
  • Associated fracture or extra-osseous component
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00503178

Contacts
Contact: Wilfried De Neve, MD, PhD + 32 9 332.30.22 wilfried.deneve@ugent.be

Locations
Belgium
University Hospital Ghent Recruiting
Ghent, Belgium, 9000
Contact: Wilfried De Neve, MD, PhD    + 32 9 332.30.22    wilfried.deneve@ugent.be   
Principal Investigator: Wilfried De Neve, MD, PhD         
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Wilfried De Neve, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00503178     History of Changes
Other Study ID Numbers: 2006/098 
Study First Received: July 17, 2007
Last Updated: December 4, 2014

Additional relevant MeSH terms:
Neoplasm Metastasis
Bone Neoplasms
Bone Marrow Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases

ClinicalTrials.gov processed this record on February 23, 2017