NCT00503178

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2006

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 18, 2007

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2015

Completed
Last Updated

December 22, 2022

Status Verified

December 1, 2022

Enrollment Period

9.1 years

First QC Date

July 17, 2007

Last Update Submit

December 20, 2022

Conditions

Bone Metastases

Outcome Measures

Primary Outcomes (1)

  • Pain assessment

    t0

Secondary Outcomes (4)

  • Acute toxicity

    t0

  • Bone remodeling

    t0

  • Resulting volumes of the targets and functional active areas

    t0

  • Mismatch and/or overlap areas

    t0

Study Arms (1)

Patients undergoing imaging guided radiotherapy.

EXPERIMENTAL
Procedure: Biological imaging guided antalgic radiotherapy

Interventions

Biological imaging guided antalgic radiotherapyPROCEDURE

Biological imaging guided antalgic radiotherapy is followed.

Patients undergoing imaging guided radiotherapy.

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Previous radiotherapy to the painful site
  • Bone metastasis from malignant melanoma or renal cell carcinoma
  • Associated fracture or extra-osseous component

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

Study Officials

  • Wilfried De Neve, MD, PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2007

First Posted

July 18, 2007

Study Start

April 1, 2006

Primary Completion

April 22, 2015

Study Completion

April 22, 2015

Last Updated

December 22, 2022

Record last verified: 2022-12

Locations

BE(1)