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NCT00503178 Clinical Trial

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

Bone Metastases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00503178
Other study ID # 2006/098
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date April 1, 2006
Est. completion date April 22, 2015

Study information
Verified date December 2022
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 54
Est. completion date April 22, 2015
Est. primary completion date April 22, 2015
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Biological imaging guided antalgic radiotherapy
Biological imaging guided antalgic radiotherapy is followed.

Locations
Country Name City State
Belgium University Hospital Ghent Ghent

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain assessment t0
Secondary Acute toxicity t0
Secondary Bone remodeling t0
Secondary Resulting volumes of the targets and functional active areas t0
Secondary Mismatch and/or overlap areas t0
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