Bone MetastasesPhase 2NCT00503178
Biological Imaging Guided Antalgic Radiotherapy of Bone Metastases (Phase II Trial)
A Phase 2 study testing Biological imaging guided antalgic radiotherapy in people with Bone Metastases, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Bone Metastases
- What is being tested?
- Biological imaging guided antalgic radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Apr 2006to 22 Apr 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Previous radiotherapy to the painful site
- Bone metastasis from malignant melanoma or renal cell carcinoma
- Associated fracture or extra-osseous component
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Bone Metastases
- Being tested
- Biological imaging guided antalgic radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological imaging guided antalgic radiotherapyProcedure or surgery
Biological imaging guided antalgic radiotherapy is followed.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing imaging guided radiotherapy. | Experimental | Not described Receives: Procedure: Biological imaging guided antalgic radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment
Measured: t0
Secondary outcomes (4)
Acute toxicity
Measured: t0
Bone remodeling
Measured: t0
Resulting volumes of the targets and functional active areas
Measured: t0
Mismatch and/or overlap areas
Measured: t0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2007 (estimated)
- Study start1 Apr 2006
- Primary completion22 Apr 2015
- Study completion22 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone MetastasesStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wilfried De Neve, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00503178
- Sponsor's protocol ID
- 2006/098
- Status last verified
- Dec 2022
- First submitted
- 17 Jul 2007
- Last updated
- 22 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Imaging Guided Antalgic Radiotherapy of Bone Metastases (Phase II Trial)
- ClinicalTrials.gov ID
- NCT00503178
- Acronym / sponsor ID
- 2006/098
- Conditions
- Bone Metastases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 1 Apr 2006 (actual)
- Primary completion
- 22 Apr 2015 (actual)
- Study completion
- 22 Apr 2015 (actual)
- First posted
- 18 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing imaging guided radiotherapy. | Experimental | Procedure: Biological imaging guided antalgic radiotherapy |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Previous radiotherapy to the painful site
- Bone metastasis from malignant melanoma or renal cell carcinoma
- Associated fracture or extra-osseous component
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological imaging guided antalgic radiotherapyBiological imaging guided antalgic radiotherapy is followed. | Procedure or surgery | Patients undergoing imaging guided radiotherapy. |
Primary outcome
Pain assessment
Time frame: t0
4 secondary outcomes
Acute toxicity
Time frame: t0
Bone remodeling
Time frame: t0
Resulting volumes of the targets and functional active areas
Time frame: t0
Mismatch and/or overlap areas
Time frame: t0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
- Website of the University Hospital GhentLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wilfried De Neve, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Biological imaging guided antalgic radiotherapy in people with Bone Metastases, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain assessment (time frame: t0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2022.