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

NCT ID: NCT00503178

Last Updated: 2022-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-01

Study Completion Date

2015-04-22

Brief Summary

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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

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Conditions

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Bone Metastases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients undergoing imaging guided radiotherapy.

Group Type EXPERIMENTAL

Biological imaging guided antalgic radiotherapy

Intervention Type PROCEDURE

Biological imaging guided antalgic radiotherapy is followed.

Interventions

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Biological imaging guided antalgic radiotherapy

Biological imaging guided antalgic radiotherapy is followed.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wilfried De Neve, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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University Hospital Ghent

Ghent, , Belgium

Site Status

Countries

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Belgium

Related Links

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http://www.uzgent.be

Website of the University Hospital Ghent

Other Identifiers

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2006/098

Identifier Type: -

Identifier Source: org_study_id