Biological Imaging Guided Antalgic Radiotherapy of Bone Metastases (Phase II Trial)
Phase 2
Completed
- Conditions
- Bone Metastases
- Interventions
- Procedure: Biological imaging guided antalgic radiotherapy
- Registration Number
- NCT00503178
- Lead Sponsor
- University Hospital, Ghent
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patients undergoing imaging guided radiotherapy. Biological imaging guided antalgic radiotherapy -
- Primary Outcome Measures
Name Time Method Pain assessment t0
- Secondary Outcome Measures
Name Time Method Acute toxicity t0 Bone remodeling t0 Resulting volumes of the targets and functional active areas t0 Mismatch and/or overlap areas t0
Trial Locations
- Locations (1)
University Hospital Ghent
🇧🇪Ghent, Belgium