Secondary Malignant Neoplasm of BonePhase 1/2NCT01693770
Primary Pain Palliation in Bone Metastases Treated With Magnetic Resonance-guided Focused Ultrasound
A Phase 1/2 study testing MRgFUS in people with Secondary Malignant Neoplasm of Bone, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
Magnetic Resonance guided Focused Ultrasound (MRgFUS) has demonstrated to be effective for pain control through thermally-induced cell death and periosteal denervation caused by cortical heating relative to acoustic energy absorption. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Secondary Malignant Neoplasm of Bone
- What is being tested?
- MRgFUS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2011to Feb 2015
- Phase
- Phase 1/2
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the presence of a known primary cancer and bone metastases confirmed by two or more imaging modalities;
- exhaustion or refusal of all other pain palliation methods including EBRT;
- confirmation of MRgFUS treatment feasibility at a preliminary MR planning examination (presence of an adequate acoustic window between the transducer, skin and target lesion and absence of bowel loops across the planned ultrasound path)
Who cannot join
- general contraindication to MR imaging (including pacemaker, ferromagnetic devices or implants)
- general contraindication to gadolinium-based contrast agents (intolerance and/or clinically proven chronic renal failure)
- general contraindication to general/epidural anesthesia or deep sedation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Primary Pain Palliation and Local Tumor Control in Bone Metastases Treated With Magnetic Resonance-guided Focused Ultrasound
Magnetic Resonance guided Focused Ultrasound (MRgFUS) has demonstrated to be effective for pain control through thermally-induced cell death and periosteal denervation caused by cortical heating relative to acoustic energy absorption. There is also evidence that a high intensity focused ultrasound beam can penetrate through the cortical bone to the medullary space, producing thermal necrosis of cancer tissue. However, little is known about the potential effects of MRgFUS as first line therapeutic modality for pain palliation in skeletal metastases.
Our hypothesis sought to assess the clinical performance of MRgFUS primary treatment of painful bone metastases and determine the potential of this technique for local tumor control.
Read the detailed description
Unlike previous studies, in which patients were enrolled for MRgFUS treatment because of the failure of other therapies, our study will be conducted in patients not previously treated with EBRT to the targeted lesion.
This is an important new feature, especially given the advantages of MRgFUS, such as lack of ionizing radiation, the ability to conduct treatment on an outpatient basis and the possibility to repeat the treatment as necessary.
- Conditions
- Secondary Malignant Neoplasm of Bone
- Being tested
- MRgFUS
- Keywords
- Bone Metastasis, Pain Palliation, High Intensity Focused Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRgFUSProcedure or surgery
Also called MRgFUS, ExAblate, InSightec, MR-HIFU, Magnetic Resonance-guided Focused Ultrasound
Focused ultrasound energy is accumulated into the target tissue (skeletal metastasis) thanks to the real time guidance of the MR images.
| Study group | Role | What they receive |
|---|---|---|
| MRgFUS | Other | High intensity focused ultrasound energy, delivered under the guidance of the MR images (MgFUS) allows for a predefined amount of energy to be delivered in the desired target (Metastasis). Bone readily absorbs focused ultrasound energy resulting in a thermo-related neurolysis of the periostium with consequent pain palliation. The amount of energy delivered can be modulated with the objective to penetrate cortical space and obtain necrosis of the metastasis thus preventing local recurrence. Receives: Procedure: MRgFUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and efficacy of Magnetic Resonance-guided Focused Ultrasound (MRgFUS) for the primary treatment of painful bone metastases
Patients will be monitored for major or minor adverse events
Measured: 6 months
Secondary outcomes (1)
To correlate the treatment response to extent of tumor necrosis as determined by follow-up imaging
necrosis of the actual lesion will be analyzed according to area on non-perfused volume at the end of the procedure
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2012 (estimated)
- Study startJan 2011
- Primary completionJan 2015 (estimated)
- Study completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary Malignant Neoplasm of BoneStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro Napoli, University of Roma La Sapienza
- Investigators
- Alessandro Napoli, MD, PhD, Principal investigator, Department of Radiological Sciences, Sapienza University of Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01693770
- Sponsor's protocol ID
- BM-MRgFUS
- Status last verified
- Jun 2014
- First submitted
- 20 Sep 2012
- Last updated
- 18 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Pain Palliation and Local Tumor Control in Bone Metastases Treated With Magnetic Resonance-guided Focused Ultrasound
- ClinicalTrials.gov ID
- NCT01693770
- Acronym / sponsor ID
- BM-MRgFUS
- Conditions
- Secondary Malignant Neoplasm of Bone
- Keywords
- Bone Metastasis, Pain Palliation, High Intensity Focused Ultrasound
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 26 Sep 2012 (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.
Magnetic Resonance guided Focused Ultrasound (MRgFUS) has demonstrated to be effective for pain control through thermally-induced cell death and periosteal denervation caused by cortical heating relative to acoustic energy absorption. There is also evidence that a high intensity focused ultrasound beam can penetrate through the cortical bone to the medullary space, producing thermal necrosis of cancer tissue. However, little is known about the potential effects of MRgFUS as first line therapeutic modality for pain palliation in skeletal metastases.
Our hypothesis sought to assess the clinical performance of MRgFUS primary treatment of painful bone metastases and determine the potential of this technique for local tumor control.
Detailed description
Unlike previous studies, in which patients were enrolled for MRgFUS treatment because of the failure of other therapies, our study will be conducted in patients not previously treated with EBRT to the targeted lesion.
This is an important new feature, especially given the advantages of MRgFUS, such as lack of ionizing radiation, the ability to conduct treatment on an outpatient basis and the possibility to repeat the treatment as necessary.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRgFUS | Other | Procedure: MRgFUSHigh intensity focused ultrasound energy, delivered under the guidance of the MR images (MgFUS) allows for a predefined amount of energy to be delivered in the desired target (Metastasis). Bone readily absorbs focused ultrasound energy resulting in a thermo-related neurolysis of the periostium with consequent pain palliation. The amount of energy delivered can be modulated with the objective to penetrate cortical space and obtain necrosis of the metastasis thus preventing local recurrence. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- the presence of a known primary cancer and bone metastases confirmed by two or more imaging modalities;
- exhaustion or refusal of all other pain palliation methods including EBRT;
- confirmation of MRgFUS treatment feasibility at a preliminary MR planning examination (presence of an adequate acoustic window between the transducer, skin and target lesion and absence of bowel loops across the planned ultrasound path)
Key exclusion criteria (3 listed)
- general contraindication to MR imaging (including pacemaker, ferromagnetic devices or implants)
- general contraindication to gadolinium-based contrast agents (intolerance and/or clinically proven chronic renal failure)
- general contraindication to general/epidural anesthesia or deep sedation
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 |
|---|---|---|
| MRgFUSAlso: MRgFUS, ExAblate, InSightec, MR-HIFU, Magnetic Resonance-guided Focused UltrasoundFocused ultrasound energy is accumulated into the target tissue (skeletal metastasis) thanks to the real time guidance of the MR images. | Procedure or surgery | MRgFUS |
Primary outcome
To evaluate the safety and efficacy of Magnetic Resonance-guided Focused Ultrasound (MRgFUS) for the primary treatment of painful bone metastases
Time frame: 6 months
Patients will be monitored for major or minor adverse events
1 secondary outcome
To correlate the treatment response to extent of tumor necrosis as determined by follow-up imaging
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 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.
Alessandro Napoli, MD, PhD principal investigator
Department of Radiological Sciences, Sapienza University of Rome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MRgFUS in people with Secondary Malignant Neoplasm of Bone, run by University of Roma La Sapienza at 1 site in Italy.
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 3 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: status not confirmed, as of the sponsor's last update on 18 Jun 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 Italy. 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 combined 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.
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?
Results are not available in the source record.
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 evaluate the safety and efficacy of Magnetic Resonance-guided Focused Ultrasound (MRgFUS) for the primary treatment of painful bone metastases (time frame: 6 months). 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 18 Jun 2014.