Biological Imaging Guided Antalgic Radiotherapy of Bone M... | NCT00503178

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

NCT00503178

Sponsor

University Hospital, Ghent

Status

Completed

Last Update Posted

Dec 22, 2022Actual

Enrollment

54Actual

Phase

Phase 2

Conditions

Bone Metastases

Interventions

Biological imaging guided antalgic radiotherapy

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2006Actual

Primary Completion Date

Apr 22, 2015Actual

Completion Date

Apr 22, 2015Actual

First Submitted Date

Jul 17, 2007

First Submission Date that Met QC Criteria

Jul 17, 2007

First Posted Date

Jul 18, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 20, 2022

Last Update Posted Date

Dec 22, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

54Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients undergoing imaging guided radiotherapy.	Experimental		Procedure: Biological imaging guided antalgic radiotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Biological imaging guided antalgic radiotherapy	Procedure	Biological imaging guided antalgic radiotherapy is followed.	Patients undergoing imaging guided radiotherapy.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain assessment		t0

Secondary Outcomes

Measure	Description	Time Frame
Acute toxicity		t0
Bone remodeling		t0
Resulting volumes of the targets and functional active areas

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wilfried De Neve, MD, PhD	University Hospital, Ghent	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Ghent		Ghent		9000	Belgium