Bone MetastasisPhase 1NCT01765907
Antalgic Treatment of Painful Bone Metastases by US-guided High Intensity Focused Ultrasound (HIFU)
A Phase 1 study testing HIFU in people with Bone Metastasis, run by Theraclion at 1 site in France.
Trial summary
Antalgic treatment of painful bone metastases by US-guided High Intensity Focused Ultrasound (HIFU). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Metastasis
- What is being tested?
- HIFU
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2012to Mar 2014
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 18 years of age or older.
- Histologically proven malignancy of primary tumor. Histologic diagnosis may be established from needle biopsy, cytology, or a surgical biopsy or resection. If the nature of the lesion has been previously through biopsy, the lesion to be treated does not require further documentation.
- Metastatic disease documented either by imaging techniques (plain radiographs, radionuclide bone scans, computed tomography scans and magnetic resonance imaging) or by histology. Other imaging techniques may be acceptable with the approval of the principal investigator.
- ≤ 3 treatable painful bone metastases.
- "Worst Pain Score" of > 3 on a scale of 10 during a 24-hour period (as scored on the Brief Pain Inventory [BPI] question #3: 0 = no pain; 10 = worst possible pain) despite level II analgesic medications.
- Prothrombin time (PT) >50%, Thrombocytes >50x109/L.
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- Estimated life expectancy of 3 months or greater, as estimated by the responsible clinician.
- Targeted tumor clearly visible in B-mode ultrasonography, and accessible to US-HIFU treatment, based on imaging data.
- Agreement from the anaesthetist for a IV conscious sedation
- Signed study-specific informed consent prior to inclusion.
- Negative pregnancy test before inclusion for women of childbearing and or efficient method of contraception.
- Patient with social security coverage.
Who cannot join
- • Pregnant or lactating women.
- Radiation therapy to the targeted sites within 30 days prior to enrollment.
- Targeted tumor mass is less than 10 mm from spinal cord, nerve bundles, bladder, bowel, or hollow viscera,
- Targeted tumor located in skull (including facial bones), vertebral body or sternum.
- Site at need for surgical stabilization
- Uncontrolled bleeding disorders.
- Hematologic primary malignancies.
- patient participating in other trials using drugs or devices
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antalgic Treatment of Painful Bone Metastases by US-guided High Intensity Focused Ultrasound (HIFU).
Antalgic treatment of painful bone metastases by US-guided High Intensity Focused Ultrasound (HIFU).
Read the detailed description
Inclusion Criteria
- 18 years of age or older.
- Histologically proven malignancy of primary tumor. Histologic diagnosis may be established from needle biopsy, cytology, or a surgical biopsy or resection. If the nature of the lesion has been previously through biopsy, the lesion to be treated does not require further documentation.
- Metastatic disease documented either by imaging techniques (plain radiographs, radionuclide bone scans, computed tomography scans and magnetic resonance imaging) or by histology. Other imaging techniques may be acceptable with the approval of the principal investigator.
- ≤ 3 treatable painful bone metastases.
- "Worst Pain Score" of > 3 on a scale of 10 during a 24-hour period (as scored on the Brief Pain Inventory [BPI] question #3: 0 = no pain; 10 = worst possible pain) despite level II analgesic medications.
- Prothrombin time (PT) >50%, Thrombocytes >50x109/L.
- Estimated life expectancy of 3 months or greater, as estimated by the responsible clinician.
- Targeted tumor clearly visible in B-mode ultrasonography, and accessible to US-HIFU treatment, based on imaging data.
- Agreement from the anaesthetist for a IV conscious sedation
- Signed study-specific informed consent prior to inclusion.
- Negative pregnancy test before inclusion for women of childbearing and or efficient method of contraception.
- Patient with social security coverage. Biphosphonate, chemotherapy or hormone therapy intake should remain stable (if possible) throughout follow-up duration.
Exclusion criteria for subject selection
- Pregnant or lactating women.
- Radiation therapy to the targeted sites within 30 days prior to enrollment.
- Targeted tumor mass is less than 10 mm from spinal cord, nerve bundles, bladder, bowel, or hollow viscera,
- Targeted tumor located in skull (including facial bones), vertebral body or sternum.
- Site at need for surgical stabilization
- Uncontrolled bleeding disorders.
- Hematologic primary malignancies.
- patient participating in other trials using drugs or devices
- Conditions
- Bone Metastasis
- Being tested
- HIFU
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIFUDevice
| Study group | Role | What they receive |
|---|---|---|
| HIFU | Experimental | Not described Receives: Device: HIFU |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess safety including adverse and serious adverse events, local and systemic tolerance of HIFU in patients with bone metastasis acoording to the Common Terminology Criteria for Adverse events (CTCAE version 4.3)
Measured: up to 3 months after HIFU session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone MetastasisStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theraclion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01765907
- Sponsor's protocol ID
- HIFU/F/BM/Feb2012.
- Status last verified
- Apr 2014
- First submitted
- 9 Jan 2013
- Last updated
- 16 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antalgic Treatment of Painful Bone Metastases by US-guided High Intensity Focused Ultrasound (HIFU).
- ClinicalTrials.gov ID
- NCT01765907
- Acronym / sponsor ID
- HIFU/F/BM/Feb2012.
- Conditions
- Bone Metastasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- TheraclionIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 10 Jan 2013 (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.
Antalgic treatment of painful bone metastases by US-guided High Intensity Focused Ultrasound (HIFU).
Detailed description
Inclusion Criteria
- 18 years of age or older.
- Histologically proven malignancy of primary tumor. Histologic diagnosis may be established from needle biopsy, cytology, or a surgical biopsy or resection. If the nature of the lesion has been previously through biopsy, the lesion to be treated does not require further documentation.
- Metastatic disease documented either by imaging techniques (plain radiographs, radionuclide bone scans, computed tomography scans and magnetic resonance imaging) or by histology. Other imaging techniques may be acceptable with the approval of the principal investigator.
- ≤ 3 treatable painful bone metastases.
- "Worst Pain Score" of > 3 on a scale of 10 during a 24-hour period (as scored on the Brief Pain Inventory [BPI] question #3: 0 = no pain; 10 = worst possible pain) despite level II analgesic medications.
- Prothrombin time (PT) >50%, Thrombocytes >50x109/L.
- Estimated life expectancy of 3 months or greater, as estimated by the responsible clinician.
- Targeted tumor clearly visible in B-mode ultrasonography, and accessible to US-HIFU treatment, based on imaging data.
- Agreement from the anaesthetist for a IV conscious sedation
- Signed study-specific informed consent prior to inclusion.
- Negative pregnancy test before inclusion for women of childbearing and or efficient method of contraception.
- Patient with social security coverage. Biphosphonate, chemotherapy or hormone therapy intake should remain stable (if possible) throughout follow-up duration.
Exclusion criteria for subject selection
- Pregnant or lactating women.
- Radiation therapy to the targeted sites within 30 days prior to enrollment.
- Targeted tumor mass is less than 10 mm from spinal cord, nerve bundles, bladder, bowel, or hollow viscera,
- Targeted tumor located in skull (including facial bones), vertebral body or sternum.
- Site at need for surgical stabilization
- Uncontrolled bleeding disorders.
- Hematologic primary malignancies.
- patient participating in other trials using drugs or devices
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIFU | Experimental | Device: HIFU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- • 18 years of age or older.
Key exclusion criteria (8 listed)
- • Pregnant or lactating women.
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 |
|---|---|---|
| HIFU | Device | HIFU |
Primary outcome
To assess safety including adverse and serious adverse events, local and systemic tolerance of HIFU in patients with bone metastasis acoording to the Common Terminology Criteria for Adverse events (CTCAE version 4.3)
Time frame: up to 3 months after HIFU session
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 16 Apr 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HIFU in people with Bone Metastasis, run by Theraclion at 1 site in France.
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 12 inclusion and 8 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 16 Apr 2014. 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 France. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
To assess safety including adverse and serious adverse events, local and systemic tolerance of HIFU in patients with bone metastasis acoording to the Common Terminology Criteria for Adverse events (CTCAE version 4.3) (time frame: up to 3 months after HIFU session). 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 16 Apr 2014.