search
Back to results

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

Primary Purpose

Bone Metastases

Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Biological imaging guided antalgic radiotherapy
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Metastases

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Ghent

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients undergoing imaging guided radiotherapy.

Arm Description

Outcomes

Primary Outcome Measures

Pain assessment

Secondary Outcome Measures

Acute toxicity
Bone remodeling
Resulting volumes of the targets and functional active areas
Mismatch and/or overlap areas

Full Information

First Posted
July 17, 2007
Last Updated
December 20, 2022
Sponsor
University Hospital, Ghent
search

1. Study Identification

Unique Protocol Identification Number
NCT00503178
Brief Title
Biological Imaging Guided Antalgic Radiotherapy of Bone Metastases (Phase II Trial)
Official Title
Biological Imaging Guided Antalgic Radiotherapy of Bone Metastases (Phase II Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2006 (Actual)
Primary Completion Date
April 22, 2015 (Actual)
Study Completion Date
April 22, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Metastases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients undergoing imaging guided radiotherapy.
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Biological imaging guided antalgic radiotherapy
Intervention Description
Biological imaging guided antalgic radiotherapy is followed.
Primary Outcome Measure Information:
Title
Pain assessment
Time Frame
t0
Secondary Outcome Measure Information:
Title
Acute toxicity
Time Frame
t0
Title
Bone remodeling
Time Frame
t0
Title
Resulting volumes of the targets and functional active areas
Time Frame
t0
Title
Mismatch and/or overlap areas
Time Frame
t0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wilfried De Neve, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Links:
URL
http://www.uzgent.be
Description
Website of the University Hospital Ghent

Learn more about this trial

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

We'll reach out to this number within 24 hrs