CClinicalTrials.gg
Sign In
TerminatedNCT03738670PERFACOOLUpdated Aug 29, 2024

Bipolar RFA of Painful Extra-spinal Bone Metastases

An interventional study of Percutaneous RFA in Multi-metastatic Cancer, sponsored by University Hospital, Strasbourg, France. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-29.

Sponsored by University Hospital, Strasbourg, France · Not applicable, Interventional, and Prevention

Why this study was terminated
recruitment difficulties
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

To evaluate the worst pain of cancer patients with painful extra-spinal bone metastases 1 month after bipolar radiofrequency ablation (RFA) performed with the Osteocool system.

02

Conditions studied

  • Multi-metastatic Cancer

Browse trials for

Keywords

  • Pain
  • Extra-spinal
  • RFA
  • Radiofrequency ablation
  • Bone metastases
03

In context

Neoplasm Metastasis

3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.

This study's enrollment of 12 is below the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 966 studies on the registry; 342 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

    1. Multi-metastatic cancer patients with at least one painful lytic bone metastasis
    1. Target lesion should correspond to a specific radiologic finding
    1. At least a moderate pain produce by target lesion (4 on a scale of 0 to 10 over the prior 24 hours with or without pain killers intake) assessed during selection evaluation
    1. Patients 18 years old
    1. Able to give written consent
    1. Life expectancy 1 months
    1. Patient affiliated to the National Health Insurance system

Exclusion criteria

Exclusion Criteria:

  1. Radiation therapy on the target tumor terminated \< 3 weeks before treatment
  2. Any contra-indication for the procedure as stated by the radiologist in terms of tumor size, proximity to neural/vascular structures making the procedure at unacceptable risk
  3. Any contra-indication for the procedure as stated by the radiologist related to patient's condition (e.g. cardiac pacemakers) making the procedure at unacceptable risk
  4. Impaired haemostasis
  5. Concurrent participation in other experimental studies that could affect endpoints of this study
  6. Contraindication to any form of sedation/anaesthesia
  7. Signs of local/systemic infection identified before procedure, in accordance with standard care
  8. Sclerotic metastases
  9. Adults under guardianship
  10. Patients under judicial protection
  11. Pregnant or breastfeeding woman
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    RFA

    Single-arm prospective observational study

    Procedure: Percutaneous RFA

Interventions

  • ProcedurePercutaneous RFA

    Single session percutaneous extra-spinal bone metastasis destruction to achieve pain relief

06

What researchers measure

Primary outcomes

  1. Percentage of responding patients reporting an improvement of at least 3 points on item 3 "the worst pain in the last 24 hours" of Brief Pain Inventory (BPI) questionnaire

    Time frame: 1 month

Secondary outcomes

  1. Comparison of the mean scores of the items 3, 5, 9B and 8 of the BPI questionnaire between the baseline and 6-month follow-up

    Time frame: 6 months

  2. Safety will be assessed according to SIR(11) / CTCAE classification

    Time frame: 6 months

  3. Mean scores variation of the morphine milligram equivalents (MME) (based on patient consumption diary) between the baseline and 6-month follow-up.

    Time frame: 6 months

  4. Percentage of responding patients defined by an improvement of at least 3 points on item 3 "the worst pain in the last 24 hours" of Brief Pain Inventory (BPI) questionnaire at 3 and 6 month follow-up.

    Time frame: 6 months

07

Study locations

1 site
  • University Hospital, Strasbourg, france
    Strasbourg, 67000, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03738670
Lead sponsor
University Hospital, Strasbourg, France
Responsible party
Sponsor
First posted
Nov 13, 2018
Start date
Jun 12, 2019
Primary completion
Dec 2, 2021
Completion
Oct 6, 2023
Last update
Aug 29, 2024

Study contacts

Luigi Roberto CAZZATO, MD
principal investigator · University Hospital, Strasbourg, France

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Neoplasm Metastasis→

Other studies from this sponsor

University Hospital, Strasbourg, France

Start the discussion