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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00503178
Enrollment
54
Registered
2007-07-18
Start date
2006-04-01
Completion date
2015-04-22
Last updated
2022-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Metastases

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.

Interventions

PROCEDUREBiological imaging guided antalgic radiotherapy

Biological imaging guided antalgic radiotherapy is followed.

Sponsors

University Hospital, Ghent
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Pain assessmentt0

Secondary

MeasureTime frame
Acute toxicityt0
Bone remodelingt0
Resulting volumes of the targets and functional active areast0
Mismatch and/or overlap areast0

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026