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
  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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
Study Start Date: April 2006
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (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
Genders Eligible for Study:   Both
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
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:
No publications provided

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: January 29, 2013
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
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 April 20, 2014