Bone Cancer MetastaticABLASPINENCT06716294
Effectiveness Of Radiofrequency Ablation And Stabilization In Metastatic Spine Lesions By Positron Emission Computed Tomography (PET-CT) Confirmation
An observational study of Bone Cancer Metastatic and Radiofrequency Ablation, run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial summary
This pilot study will try to demonstrate metabolic changes in spine lesions treated by Augmentation and Ablation, according to existing standards of practice. Our purpose is to show the efficacy of a new radiofrequency ablation (RFA) in combination with augmentation, using a percutaneous ablation device… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Bone Cancer Metastatic, Radiofrequency Ablation, Spine Metastases
- What is being tested?
- Radiofrequency Ablation and Bone Augmentation
- Type of treatment
- Medical device
- How many people
- 16 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jan 2023to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Sixteen (16) patients will be enorolled. * - only patients with secondary osteolytic and mixed (lytic and sclerotic) spine tumors with one to three active lesions will be enrolled. * lesions to be treated must be metabolically active on PET-CT performed during the last month. * Patients will be informed and sould sign an inform consent. * post treatment patients should submittes a new PET-CT in order to verify the activity of the treated area.
Who may be able to join
- only patients with secondary osteolytic and mixed (lytic and sclerotic) spine tumors with one to three active lesions will be enrolled.
- lesions to be treated must be metabolically active on PET-CT performed during the last month.
- Patients will be informed and sould sign an inform consent.
- post treatment patients should submittes a new PET-CT in order to verify the activity of the treated area.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
MARIA IOANNIDI, MD contact
Greece1 site, 1 recruiting
- Recruiting
3rd Department of Radiology, NKUOA, General Hospital "LAIKON"
Athens, Athens, 11527
Alexis Kelekis, MD, PhD, EBIR, +302132061284, akelekis@laikon.gr
About this study
Official title: Effectiveness Of Radiofrequency Ablation And Stabilization In Metastatic Spine Lesions By PET-CT Confirmation
This pilot study will try to demonstrate metabolic changes in spine lesions treated by Augmentation and Ablation, according to existing standards of practice. Our purpose is to show the efficacy of a new radiofrequency ablation (RFA) in combination with augmentation, using a percutaneous ablation device (Osteocool-Medtronic) in the treatment of secondary vertebral bone tumor, avoiding concurrent bias related to other treatments of the disease.
Read the detailed description
Only patient supposed to undergo percutaneous vertebral augmentation for secondary osteolytic and mixed (lytic and sclerotic) spine tumors with one to three active lesions will be enrolled. Lesions to be treated must be metabolically active on Positronic Emission Computed Tomography (PET-CT), performed during the last month. Patients will be informed and sign and inform consent. Patients will be treated with Augmentation and Ablation (Osteocool-Medtronic). Post treatment patients will be submitted to a new PET-CT in order to verify activity on treated site.
- Being tested
- Radiofrequency Ablation and Bone Augmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency Ablation and Bone AugmentationDevice
Also called Vertebroplasty
Percutaneous Tumor Ablation of Spine Lesions followed by Polymer Augmentation
What is being measured
The primary outcome is the main question the study is designed to answer.
PET-CT
Positron Emission Tomography (PET) Activity
Measured: SUV measurement of PET in 24 hours
Secondary outcomes (1)
Greek Brief Pain Index (GBPI)
NUMERIC VISUAL SCORE (NVS) OF PAIN AND MOBLITY
Measured: 1 MONTH, 6 MONTHS, 12 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start1 Jan 2023
- Primary completion1 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Cancer MetastaticStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexis Kelekis, National and Kapodistrian University of Athens
- Investigators
- ALEXIOS KELEKIS, MD, PHD, Principal investigator, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06716294
- Sponsor's protocol ID
- 46351/2020
- Acronym
- ABLASPINE
- Status last verified
- Apr 2026
- First submitted
- 29 Nov 2024
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Of Radiofrequency Ablation And Stabilization In Metastatic Spine Lesions By PET-CT Confirmation
- ClinicalTrials.gov ID
- NCT06716294
- Acronym / sponsor ID
- ABLASPINE / 46351/2020
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 4 Dec 2024 (actual)
- 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.
This pilot study will try to demonstrate metabolic changes in spine lesions treated by Augmentation and Ablation, according to existing standards of practice. Our purpose is to show the efficacy of a new radiofrequency ablation (RFA) in combination with augmentation, using a percutaneous ablation device (Osteocool-Medtronic) in the treatment of secondary vertebral bone tumor, avoiding concurrent bias related to other treatments of the disease.
Detailed description
Only patient supposed to undergo percutaneous vertebral augmentation for secondary osteolytic and mixed (lytic and sclerotic) spine tumors with one to three active lesions will be enrolled. Lesions to be treated must be metabolically active on Positronic Emission Computed Tomography (PET-CT), performed during the last month. Patients will be informed and sign and inform consent. Patients will be treated with Augmentation and Ablation (Osteocool-Medtronic). Post treatment patients will be submitted to a new PET-CT in order to verify activity on treated site.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Sixteen (16) patients will be enorolled. * - only patients with secondary osteolytic and mixed (lytic and sclerotic) spine tumors with one to three active lesions will be enrolled. * lesions to be treated must be metabolically active on PET-CT performed during the last month. * Patients will be informed and sould sign an inform consent. * post treatment patients should submittes a new PET-CT in order to verify the activity of the treated area.
Key inclusion criteria (4 listed)
- only patients with secondary osteolytic and mixed (lytic and sclerotic) spine tumors with one to three active lesions will be enrolled.
- lesions to be treated must be metabolically active on PET-CT performed during the last month.
- Patients will be informed and sould sign an inform consent.
- post treatment patients should submittes a new PET-CT in order to verify the activity of the treated area.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Radiofrequency Ablation and Bone AugmentationAlso: VertebroplastyPercutaneous Tumor Ablation of Spine Lesions followed by Polymer Augmentation | Device | – |
Primary outcome
PET-CT
Time frame: SUV measurement of PET in 24 hours
Positron Emission Tomography (PET) Activity
1 secondary outcome
Greek Brief Pain Index (GBPI)
Time frame: 1 MONTH, 6 MONTHS, 12 MONTHS
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
MARIA IOANNIDI, MD contact
ALEXIOS KELEKIS, MD, PHD principal investigator
National and Kapodistrian University of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Cancer Metastatic and Radiofrequency Ablation, run by National and Kapodistrian University of Athens at 1 site in Greece.
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 4 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 9 Apr 2026. 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 Greece. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexis Kelekis, MD PHD, EBIR (+302105831806, akelekis@med.uoa.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PET-CT (time frame: SUV measurement of PET in 24 hours). 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 9 Apr 2026.