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Bone MetastasesNCT05250687

MR Guided Focused Ultrasound vs Radiotherapy for Palliative Pain Tx in Bone Metastases

A study testing MR- High intensity focused ultrasound and External beam radiotherapy in people with Bone Metastases, run by Stanford University at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a prospective, single-center, randomized study directly comparing outcomes after MR guided high intensity focused ultrasound (MR HIFU) or external beam radiation therapy (EBRT) treatment of painful bone metastases. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bone Metastases
What is being tested?
MR- High intensity focused ultrasound and External beam radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Jun 2024to Dec 2024
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

  • Age ≥ 18 years
  • Painful metastatic bone lesions, with NRS > 4 documented at screening visit
  • Pain from target lesion is distinguishable from other lesions*
  • Target lesion lovation is accessible for MR-HIFU and EBRT**
  • Target lesion is visible om MR or CT imaging obtained < 3 months prior to screening, with a maximum diameter of 8 cm.
  • Reasonable performance score (KPS > 50% or ECOG <3)
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  • Life expectancy > 3 months as determined by the study PI or referring oncologist
  • Ability to understand and the willingness to personally sign the written IRB-approved informed consent document
  • Solitary painful metastatic bone lesion or multiple metastatic lesions with one predominantly painful target lesion (≥2 points higher pain score than other lesions).
  • e.g.: Extremities, pelvis (os pubis, os ilium, os ischium, sacrum, acetabulum), shoulders, in selected cases ribs and sternum

Who cannot join

  • Previous surgery, radiation, HIFU, or other local therapy on the target location
  • Neurological symptoms due to nerve involvement of target lesion
  • Need for surgery of targeted location due to (impending) pathological fracture
  • Unavoidable critical structures or dense tissues in target area*
  • Curative intention of treatment plan
  • Patients with contraindication for MR imaging such as implanted metallic devices that are not MRI - safe, size limitations, claustrophobia, etc.
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  • Patients with known intolerance or allergy to MR contrast agent (gadolinium chelates) including advanced kidney disease (GFR <30mL/min/1.73 m^2) or on dialysis
  • Pregnant and nursing patients will be excluded from the study because of a contraindication to administering MRI contrast agents to these patients
  • Patients unable to receive general anesthesia, as determinded by anesthesiologist, study PI or referring oncologist
  • Individuals who are not able or willing to tolerate the required prolonged stationary position during treatment (can be up to 4 hrs of total table time) via self report
  • Participant enrolled in another clinical interventional study related to bone metastases treatment or pain relief treatment
  • Clinically relevant medical history or physical findings that could interfere with the patient's safety as judged by the treating physician
  • as judged by the operator. e.g.: nerve bundles, skin, extensive scarring, non-targeted bones, air (e.g. hollow viscera), (external) fixation device

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford University

    Palo Alto, California, 94306

Other trials in United States

About this study

Official title: MR Guided Focused Ultrasound Versus Radiotherapy for Palliative Pain Treatment in Patients With Bone Metastases

This is a prospective, single-center, randomized study directly comparing outcomes after MR guided high intensity focused ultrasound (MR HIFU) or external beam radiation therapy (EBRT) treatment of painful bone metastases.

Read the detailed description

The primary purpose of this study is to see if MR guided high intensity focused ultrasound (MR-HIFU) treats bone pain faster than the standard radiation therapy (External beam radiation therapy: EBRT) and to evaluate the patient's pain experience 14 days after completion of the treatment. The secondary purpose is to evaluate the outcomes of the pain, side effects, and quality of life and survival in the first 6 months after treatment.

Conditions
Bone Metastases
Being tested
MR- High intensity focused ultrasound, External beam radiotherapy

What participants receive

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

  • MR- High intensity focused ultrasoundProcedure or surgery

    Also called MR-HIFU

    The intervention treatment is MR-HIFU, which will be given as a standalone treatment. MRHIFU treatment will be delivered using the ExAblate 2100 System (INSIGHTEC, Tirat Carmel, Israel), which is an FDA-approved device for pain palliation of bone metastasesThe ExAblate focused ultrasound device operates in conjunction with an MRI machine. Gadavist is being administered intraveneously as contrast medium for MRI.

  • External beam radiotherapyRadiation

    Also called EBRT

    Standard of care for pain palliation of bone metastases consists of single fraction external beam radiotherapy of 8-16 Gray (Gy) or a multi-fraction regime of 20 Gy in 5 fractions, 24 Gy in 6 fractions or 30 Gy in 10 fractions. The radiation schedule is at the discretion of the treating radiation oncologist.

Study groups in NCT05250687
Study groupRoleWhat they receive
MR guided high intensity focused ultrasound (MR-HIFU)ExperimentalMRHIFU treatment will be delivered using the ExAblate 2100 System (INSIGHTEC, Tirat Carmel, Israel), which is an FDA-approved device for pain palliation of bone metastases.
Receives: Procedure: MR- High intensity focused ultrasound
External beam radiation therapy (EBRT)Active comparatorPatients will undergo radiotherapy for painful bone metastases.
Receives: Radiation: External beam radiotherapy

What is being measured

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

  1. Number of participants that achieve a complete response (CR) or partial response (PR)

    Complete response (CR): Complete response is defined as a pain score of zero at the treated site with no concomitant increase in analgesic intake (stable or reducing analgesics in daily oral morphine equivalents). Partial Response (PR): Partial response is to be defined as any of the following: Pain reduction of 2 or more points at the treated site on a 0-10 scale without analgesic increase; or analgesic dose reduction of 25% or more in daily morphine equivalent from baseline without an increase in pain.

    Measured: 14 days after treatment

Secondary outcomes (9)

  1. Patient-reported pain scores - Pain Diary

    Patient reported pain scores will be based on a Numeric Rating Scale (NRS) (from 0 to 10) 0 = no pain and 10= worst pain. Assessed using the patient pain diary from treatment day to 1 month after completion treatment.

    Measured: 1 month

  2. Patient-reported pain scores - BPI (Brief Pain Inventory)

    The BPI measures pain interference on seven 0-10 integer subscales, as well as the mean of the seven subscales.

    Measured: on baseline, at 2 and 4 weeks, and at 3 and 6 months

  3. Physician-reported adverse events

    Assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0; we will report the number of pathologic fractures at the site of treatment

    Measured: on baseline, at 2 and 4 weeks, and at 3 and 6 months

  4. Patient-reported quality of life - EORTC QLQ-BM22

    During follow up, patient will received quality of life questionnaire on baseline, at 2 and 4 weeks, and at 3 and 6 months after completion of treatment.

    Measured: on baseline, at 2 and 4 weeks, and at 3 and 6 months

  5. Patient-reported quality of life - EORTC QLQ-C15-PAL

    During follow up, patient will received quality of life questionnaire on baseline, at 2 and 4 weeks, and at 3 and 6 months after completion of treatment.

    Measured: on baseline, at 2 and 4 weeks, and at 3 and 6 months

  6. Patient-reported quality of life - EQ-5D-5L

    During follow up, patient will received quality of life questionnaire on baseline, at 2 and 4 weeks, and at 3 and 6 months after completion of treatment.

    Measured: on baseline, at 2 and 4 weeks, and at 3 and 6 months

  7. Patient-reported quality of life - PGIC

    During follow up, patient will received quality of life questionnaire on baseline, at 2 and 4 weeks, and at 3 and 6 months after completion of treatment. Patient Global Impression of Change scale has a single question with a 7 point likert scale about overall improvement after treatment assessing change in pain, from "Much Better" to "Much Worse"

    Measured: on baseline, at 2 and 4 weeks, and at 3 and 6 months

  8. Local tumor control

    Assessed using CT and/or MRI imaging at three and/or six months after completion of treatment

    Measured: 3 and 6 months after completion of treatment

  9. Anxiety and depression scores

    Assessed by the Hospital Anxiety and Depression Scale (HADS). This measures anxiety and depression separately on seven four-point (0-3) subscales, giving total scores from 0-21 for both constructs.

    Measured: on baseline, at 2 and 4 weeks, and at 3 and 6 months

Timeline

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

  1. First posted22 Feb 2022
  2. Study startJun 2024 (estimated)
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Why it stopped: Insigthec is no longer seeking support of the device used for this clinical trial

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05250687
Sponsor's protocol ID
IRB-62458
Status last verified
Sep 2024
First submitted
1 Feb 2022
Last updated
1 Oct 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing MR- High intensity focused ultrasound and External beam radiotherapy in people with Bone Metastases, run by Stanford University at 1 site in United States.

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 13 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: withdrawn, as of the sponsor's last update on 1 Oct 2024. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.

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?

Number of participants that achieve a complete response (CR) or partial response (PR) (time frame: 14 days after treatment). 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 NCT05250687.

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 1 Oct 2024.

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