Secondary Bone CancerNCT03404362

MRgFUS Versus EBRT in Patients With Metastatic Non-spinal Bone Disease

A study testing Bone Metastases Pain treatment in people with Secondary Bone Cancer and Bone Metastases, run by University of Roma La Sapienza at 2 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of this trial is to collect and compare safety and effectiveness data of Magnetic Resonance guided Focused Ultrasound (MRgFUS) using the ExAblate 2100 device and radiotherapy in the treatment of metastatic bone tumors. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Secondary Bone Cancer, Bone Metastases
What is being tested?: Bone Metastases Pain treatment
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 198 participants
Where: 2 sitesItaly
Study dates: Jan 2017to Sep 2020
Phase: Interventional
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

Men and women age 18 years and older.
Able and willing to give consent and to attend all study visits
Patients with bone metastasis or primary bone lesion identifiable by imaging techniques.
Worst NRS Pain Score of ≥ 4 from the tumor to be treated.
Each targeted tumor is accessible to both ExAblate and EBRT (ExAblate accessible lesions are located in ribs, extremities (excluding joints), pelvis, shoulders and in the posterior aspects of the following spinal vertebra: Lumbar vertebra (L3 - L5), Sacral vertebra (S1 - S5), please see ExAblate "Information for Prescribers".
Targeted tumor area is smaller than 100cm2.

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Tumor clearly visible by non-contrast MRI.
No radiation therapy to selected lesion during one month prior to enrollment.
Radiation therapy to selected lesion is not contraindicated
Bisphosphonate, chemo or hormone therapy intake should remain stable throughout follow up duration.

Who cannot join

Patients who either need pre-treatment surgical stabilization of the affected bony structure
Targeted tumor is in a vertebra body or in the posterior aspects of the vertebral column other than Lumbar vertebra (L3 - L5) and Sacral vertebra (S1 - S5).
Targeted tumor is in the skull.
Patients on anti-coagulation therapy or with an underlying uncontrolled bleeding disorder.
Patients with life expectancy < 6-Months.
Patients with unstable cardiac status including:

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Unstable angina pectoris on medication.
Patients with documented myocardial infarction within last 40 days to protocol entry.
Congestive heart failure NYHA Class IV
Severe hypertension (diastolic BP > 100 on medication).
Patients with standard contraindications for MR imaging such as non-MRI compatible implanted ferromagnetic objects/devices.
Known intolerance or allergies to MRI contrast agent (e.g. Gadolinium or Magnevist)
KPS score of below 60
Severe cerebro-vascular disease (multiple CVA or CVA within 6 months)
Individuals who are not able or willing to tolerate the required prolonged stationary position during treatment (approximately 2 hrs.)
Target tumor is less then 1cm from spinal cord, skin, or hollow viscera.

Trial locations and contacts

2 sites in 1 country.

Italy2 sites

Alessandro Napoli
Rome, 00100
Sapienza University of Rome, Policlinico Umberto I Hospital
Rome

Other trials in Italy

About this study

Official title: A Two-center Phase II, Non-randomized Study of MRgFUS Versus EBRT in Patients With Metastatic Non-spinal Bone Disease: Palliative Strategy for Cancer-Induced Bone Pain

This study is designed as a prospective, double arm, non-randomized study with External Beam radiation therapy (EBRT) serving as control arm.

The study hypothesis is that MRgFUS is an effective non-invasive and safe treatment for the palliation of metastatic bone tumors with a low incidence of co-morbidity as compared to EBRT.

Read the detailed description

This is a prospective, phase II, open-label, non-randomized, double arm study to collect data on safety and effectiveness of ExAblate MRgFUS and EBRT treatments of metastatic bone tumors. Following treatment assignment and treatment itself, subjects will be followed for up for 12 months to evaluate pain relief as well as quality of life. Additional data regarding dosage and frequency of analgesic consumption for the management of the bone tumor induced pain will also be collected. MRI of the treated lesion will be obtained 3 and 6 months post therapy to evaluate effect on the lesion in both radiation and MRgFUS arms. This is clinically acceptable and widely utilized diagnostic method in follow up of this patient population.

Data will be collected for a total of 184 patients, 92 patients treated by EBRT and another 92 patients treated by FUS.

Treating physician, as of his/her normal practice, might offer additional treatment of other type in cases where pain score of the treated lesion will not improve by at least 2 points, and will remain 4 or greater. Additional treatment may be performed up to one month following treatment. Prior to offering alternative treatment, an MRI will be performed to evaluate effect on the lesion. Patient receiving another treatment, different from the initial one (i.e. patient initially treated with FUS is now treated by EBRT) will be considered as treatment failures for the primary analysis and their post-x-over follow-up results will be analyzed separately.

Conditions: Secondary Bone Cancer, Bone Metastases
Being tested: Bone Metastases Pain treatment
Keywords: Bone Metastases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bone Metastases Pain treatmentProcedure or surgery
Comparative treatments to test if MRgFUS is an effective non-invasive and safe treatment for the palliation of metastatic bone tumors with a low incidence of co-morbidity as compared to EBRT (gold-standard)

Study groups in NCT03404362
Study group	Role	What they receive
MRgFUS	Active comparator	The treatment process begins with the physician acquiring a set of MR images, identifying target volume(s) of tissue to ablate, and then drawing the treatment contours. The therapy planning software computes the type and number of sonications required to treat the defined region while minimizing total treatment time. MR images taken during the sonication provide a diagnostic quality image of the target tissue and a quantitative, real-time temperature map overlay to confirm the therapeutic effect of the treatment Receives: Procedure: Bone Metastases Pain treatment
EBRT	Active comparator	Patient would undergo single fraction of external beam radiation to a dose of 8Gy or a session of 10 fractions of external beam radiations at 3Gy per fraction for two weeks. Receives: Procedure: Bone Metastases Pain treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

Determine the effect of MRgFUS in terms of level of pain relief and decrease in analgesics/opiate and improved quality of life.
The key points that this study will capture are as follows:
Capture patient-based pain assessment using a NRS pain scale of 0-10 with anchored points in conjunction with a body diagram, capturing worst and average pain score.
Response rates were defined as follows:
1. Complete response: NRS of 0 with no concomitant increase in analgesic intake (stable or reduced OMED);
2. Partial response: a reduction in NRS ≥ 2 points from baseline without an analgesic increase or analgesic reduction ≥ 25% from baseline without an increase in pain;
3. Pain progression: an increase in NRS ≥ 2 points above baseline with stable OMED or an increase ≥ 25% in OMED from baseline with NRS stable or 1 point above baseline;
4. Indeterminate response: any response not captured by definitions 1, 2 and 3
Measured: one month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2017Sep 2020

First posted19 Jan 2018
Study startJan 2017
Primary completionMay 2019
Study completionSep 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Secondary Bone CancerStudies 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 N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 198 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03404362
Sponsor's protocol ID: BM-Fus Vs RT
Status last verified: Feb 2022
First submitted: 11 Jan 2018
Last updated: 17 Feb 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Anzidei M, Napoli A, Sacconi B, Boni F, Noce V, Di Martino M, Saba L, Catalano C. Magnetic resonance-guided focused ultrasound for the treatment of painful bone metastases: role of apparent diffusion coefficient (ADC) and dynamic contrast enhanced (DCE) MRI in the assessment of clinical outcome. Radiol Med. 2016 Dec;121(12):905-915. doi: 10.1007/s11547-016-0675-9. Epub 2016 Aug 27.
PubMed 27567615
Huisman M, ter Haar G, Napoli A, Hananel A, Ghanouni P, Lovey G, Nijenhuis RJ, van den Bosch MA, Rieke V, Majumdar S, Marchetti L, Pfeffer RM, Hurwitz MD. International consensus on use of focused ultrasound for painful bone metastases: Current status and future directions. Int J Hyperthermia. 2015 May;31(3):251-9. doi: 10.3109/02656736.2014.995237. Epub 2015 Feb 13.
PubMed 25677840
Hurwitz MD, Ghanouni P, Kanaev SV, Iozeffi D, Gianfelice D, Fennessy FM, Kuten A, Meyer JE, LeBlang SD, Roberts A, Choi J, Larner JM, Napoli A, Turkevich VG, Inbar Y, Tempany CM, Pfeffer RM. Magnetic resonance-guided focused ultrasound for patients with painful bone metastases: phase III trial results. J Natl Cancer Inst. 2014 Apr 23;106(5):dju082. doi: 10.1093/jnci/dju082.
PubMed 24760791
Napoli A, Anzidei M, Marincola BC, Brachetti G, Noce V, Boni F, Bertaccini L, Passariello R, Catalano C. MR imaging-guided focused ultrasound for treatment of bone metastasis. Radiographics. 2013 Oct;33(6):1555-68. doi: 10.1148/rg.336125162.
PubMed 24108551
Napoli A, Anzidei M, Marincola BC, Brachetti G, Ciolina F, Cartocci G, Marsecano C, Zaccagna F, Marchetti L, Cortesi E, Catalano C. Primary pain palliation and local tumor control in bone metastases treated with magnetic resonance-guided focused ultrasound. Invest Radiol. 2013 Jun;48(6):351-8. doi: 10.1097/RLI.0b013e318285bbab.
PubMed 23571832

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Secondary Bone Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Two-center Phase II, Non-randomized Study of MRgFUS Versus EBRT in Patients With Metastatic Non-spinal Bone Disease: Palliative Strategy for Cancer-Induced Bone Pain
ClinicalTrials.gov ID: NCT03404362
Acronym / sponsor ID: BM-Fus Vs RT
Conditions: Secondary Bone Cancer, Bone Metastases
Keywords: Bone Metastases
Study type: Interventional
Recruitment status: Completed
Enrolment: 198 participants (actual)
Lead sponsor: University of Roma La SapienzaUniversity, hospital or other
Study start: Jan 2017 (actual)
Primary completion: May 2019 (actual)
Study completion: Sep 2020 (actual)
First posted: 19 Jan 2018 (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 study is designed as a prospective, double arm, non-randomized study with External Beam radiation therapy (EBRT) serving as control arm.

The study hypothesis is that MRgFUS is an effective non-invasive and safe treatment for the palliation of metastatic bone tumors with a low incidence of co-morbidity as compared to EBRT.

Detailed description

Data will be collected for a total of 184 patients, 92 patients treated by EBRT and another 92 patients treated by FUS.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
MRgFUS	Active comparator	Procedure: Bone Metastases Pain treatmentThe treatment process begins with the physician acquiring a set of MR images, identifying target volume(s) of tissue to ablate, and then drawing the treatment contours. The therapy planning software computes the type and number of sonications required to treat the defined region while minimizing total treatment time. MR images taken during the sonication provide a diagnostic quality image of the target tissue and a quantitative, real-time temperature map overlay to confirm the therapeutic effect of the treatment
EBRT	Active comparator	Procedure: Bone Metastases Pain treatmentPatient would undergo single fraction of external beam radiation to a dose of 8Gy or a session of 10 fractions of external beam radiations at 3Gy per fraction for two weeks.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Men and women age 18 years and older.
Able and willing to give consent and to attend all study visits
Patients with bone metastasis or primary bone lesion identifiable by imaging techniques.
Worst NRS Pain Score of ≥ 4 from the tumor to be treated.
Each targeted tumor is accessible to both ExAblate and EBRT (ExAblate accessible lesions are located in ribs, extremities (excluding joints), pelvis, shoulders and in the posterior aspects of the following spinal vertebra: Lumbar vertebra (L3 - L5), Sacral vertebra (S1 - S5), please see ExAblate "Information for Prescribers".

Key exclusion criteria (16 listed)

Patients who either need pre-treatment surgical stabilization of the affected bony structure
Targeted tumor is in a vertebra body or in the posterior aspects of the vertebral column other than Lumbar vertebra (L3 - L5) and Sacral vertebra (S1 - S5).
Targeted tumor is in the skull.
Patients on anti-coagulation therapy or with an underlying uncontrolled bleeding disorder.
Patients with life expectancy < 6-Months.

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
Bone Metastases Pain treatmentComparative treatments to test if MRgFUS is an effective non-invasive and safe treatment for the palliation of metastatic bone tumors with a low incidence of co-morbidity as compared to EBRT (gold-standard)	Procedure or surgery	EBRT, MRgFUS

Primary outcome

Determine the effect of MRgFUS in terms of level of pain relief and decrease in analgesics/opiate and improved quality of life.
Time frame: one month
The key points that this study will capture are as follows: Capture patient-based pain assessment using a NRS pain scale of 0-10 with anchored points in conjunction with a body diagram, capturing worst and average pain score. Response rates were defined as follows: 1. Complete response: NRS of 0 with no concomitant increase in analgesic intake (stable or reduced OMED); 2. Partial response: a reduction in NRS ≥ 2 points from baseline without an analgesic increase or analgesic reduction ≥ 25% from baseline without an increase in pain; 3. Pain progression: an increase in NRS ≥ 2 points above baseline with stable OMED or an increase ≥ 25% in OMED from baseline with NRS stable or 1 point above baseline; 4. Indeterminate response: any response not captured by definitions 1, 2 and 3

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 17 Feb 2022.
Background: PubMed 27567615Anzidei M, Napoli A, Sacconi B, Boni F, Noce V, Di Martino M, Saba L, Catalano C. Magnetic resonance-guided focused ultrasound for the treatment of painful bone metastases: role of apparent diffusion coefficient (ADC) and dynamic contrast enhanced (DCE) MRI in the assessment of clinical outcome. Radiol Med. 2016 Dec;121(12):905-915. doi: 10.1007/s11547-016-0675-9. Epub 2016 Aug 27.
Background: PubMed 25677840Huisman M, ter Haar G, Napoli A, Hananel A, Ghanouni P, Lovey G, Nijenhuis RJ, van den Bosch MA, Rieke V, Majumdar S, Marchetti L, Pfeffer RM, Hurwitz MD. International consensus on use of focused ultrasound for painful bone metastases: Current status and future directions. Int J Hyperthermia. 2015 May;31(3):251-9. doi: 10.3109/02656736.2014.995237. Epub 2015 Feb 13.
Background: PubMed 24760791Hurwitz MD, Ghanouni P, Kanaev SV, Iozeffi D, Gianfelice D, Fennessy FM, Kuten A, Meyer JE, LeBlang SD, Roberts A, Choi J, Larner JM, Napoli A, Turkevich VG, Inbar Y, Tempany CM, Pfeffer RM. Magnetic resonance-guided focused ultrasound for patients with painful bone metastases: phase III trial results. J Natl Cancer Inst. 2014 Apr 23;106(5):dju082. doi: 10.1093/jnci/dju082.
Background: PubMed 24108551Napoli A, Anzidei M, Marincola BC, Brachetti G, Noce V, Boni F, Bertaccini L, Passariello R, Catalano C. MR imaging-guided focused ultrasound for treatment of bone metastasis. Radiographics. 2013 Oct;33(6):1555-68. doi: 10.1148/rg.336125162.
Background: PubMed 23571832Napoli A, Anzidei M, Marincola BC, Brachetti G, Ciolina F, Cartocci G, Marsecano C, Zaccagna F, Marchetti L, Cortesi E, Catalano C. Primary pain palliation and local tumor control in bone metastases treated with magnetic resonance-guided focused ultrasound. Invest Radiol. 2013 Jun;48(6):351-8. doi: 10.1097/RLI.0b013e318285bbab.
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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Bone Metastases Pain treatment in people with Secondary Bone Cancer and Bone Metastases, run by University of Roma La Sapienza at 2 sites 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 10 inclusion and 16 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 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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.

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?

Determine the effect of MRgFUS in terms of level of pain relief and decrease in analgesics/opiate and improved quality of life. (time frame: one month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03404362, which also lists 5 linked publications.

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 17 Feb 2022.