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

• Sponsor: University Hospital, Ghent (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00503178
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Duration (Months): 111
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bone Metastases	Procedure: Biological imaging guided antalgic radiotherapy	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Biological Imaging Guided Antalgic Radiotherapy of Bone Metastases (Phase II Trial)
• Study Start Date: Apr 1, 2006
• Anticipated Primary Completion Date: Jul 1, 2015
• Anticipated Study Completion Date: Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients undergoing imaging guided radiotherapy.	Procedure: Biological imaging guided antalgic radiotherapy; Biological imaging guided antalgic radiotherapy is followed.

Outcome Measures

Primary Outcome Measures

1. Pain assessment [t0]

Secondary Outcome Measures

1. Acute toxicity [t0]

2. Bone remodeling [t0]

3. Resulting volumes of the targets and functional active areas [t0]

4. Mismatch and/or overlap areas [t0]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Ghent	Ghent		Belgium	9000

Sponsors and Collaborators

• University Hospital, Ghent

Investigators

• Principal Investigator: Wilfried De Neve, MD, PhD, University Hospital, Ghent

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Website of the University Hospital Ghent

Publications

None provided.

• Responsible Party: University Hospital, Ghent
• ClinicalTrials.gov Identifier: NCT00503178
• Other Study ID Numbers: 2006/098
• First Posted: Jul 18, 2007
• Last Update Posted: Dec 5, 2014
• Last Verified: Dec 1, 2014

• Additional relevant MeSH terms: Neoplasm Metastasis; Bone Neoplasms; Bone Marrow Diseases

Study Results

No Results Posted as of Dec 5, 2014