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Completed

NCT Number: NCT00503178

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.

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Key information

Conditions

Bone Metastases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital Ghent

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biological imaging guided antalgic radiotherapy

Procedure

Biological imaging guided antalgic radiotherapy is followed.

Primary outcomes

  1. Pain assessment

    Time frame: t0

Secondary outcomes

  1. Acute toxicity

    Time frame: t0

  2. Bone remodeling

    Time frame: t0

  3. Resulting volumes of the targets and functional active areas

    Time frame: t0

  4. Mismatch and/or overlap areas

    Time frame: t0

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Important dates

Study start
2006
Primary completion
2015
Study completion
2015
First posted
Jul 18, 2007
Registry last updated
Dec 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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