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

This study is currently recruiting participants.
Verified January 2013 by University Hospital, Ghent
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00503178
First received: July 17, 2007
Last updated: January 29, 2013
Last verified: January 2013
History of Changes

July 17, 2007
January 29, 2013
April 2006
July 2013   (final data collection date for primary outcome measure)
Pain assessment [ Time Frame: t0 ] [ Designated as safety issue: No ]
Pain assessment
Complete list of historical versions of study NCT00503178 on ClinicalTrials.gov Archive Site
  • Acute toxicity [ Time Frame: t0 ] [ Designated as safety issue: No ]
  • Bone remodeling [ Time Frame: t0 ] [ Designated as safety issue: No ]
  • Resulting volumes of the targets and functional active areas [ Time Frame: t0 ] [ Designated as safety issue: No ]
  • Mismatch and/or overlap areas [ Time Frame: t0 ] [ Designated as safety issue: No ]
  • Acute toxicity
  • Bone remodeling
  • Resulting volumes of the targets and functional active areas
  • Mismatch and/or overlap areas
Not Provided
Not Provided
 
Biological Imaging Guided Antalgic Radiotherapy of Bone Metastases (Phase II Trial)
Biological Imaging Guided Antalgic Radiotherapy of Bone Metastases (Phase II Trial)

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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Bone Metastases
Procedure: Biological imaging guided antalgic radiotherapy
Biological imaging guided antalgic radiotherapy is followed.
Experimental: Patients undergoing imaging guided radiotherapy.
Intervention: Procedure: Biological imaging guided antalgic radiotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
July 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact: Wilfried De Neve, MD, PhD + 32 9 332.30.22 wilfried.deneve@ugent.be
Belgium
 
NCT00503178
2006/098
No
University Hospital, Ghent
University Hospital, Ghent
Not Provided
Principal Investigator: Wilfried De Neve, MD, PhD University Hospital, Ghent
University Hospital, Ghent
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP