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Bone MetastasesPhase 1/2PRE-FURTHERNCT04310410

Feasibility of Combined Focused Ultrasound and Radiotherapy Treatment in Patients With Painful Bone Metastasis

A Phase 1/2 study testing combined radiotherapy and MR-HIFU in people with Bone Metastases and Bone Neoplasm, run by UMC Utrecht at 2 sites in Netherlands.

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 PRE-FURTHER study aims to evaluate the feasibility of the combined treatment with radiotherapy and focussed ultrasound for pain palliation in patients with painful bone metastases, and to optimize the combined treatment logistics. Six to ten patients will be included according to in- and exclusion criteria. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bone Metastases, Bone Neoplasm, Bone Lesion
What is being tested?
combined radiotherapy and MR-HIFU
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
2 sitesNetherlands
Study dates
11 Apr 2019to 1 Jun 2020
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women with age ≥ 18 years
  • Patient capable of giving informed consent and able to attend study visits
  • Uncomplicated painful bone metastases
  • Weight <140kg and able to fit in the MRI gantry
  • Radiologic evidence of bone metastases from any solid tumor
  • Pain is localized to the targeted area, or is likely to be referred pain arising from the targeted area
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  • Pain related to the target lesion is refractory to less invasive treatments for pain relief
  • Multiple metastatic lesions, with one predominantly painful lesion (>=2 points higher pain score than other lesions). The lesion should be clearly distinguishable from other painful lesions.
  • Device accessible tumors: extremities (excluding joints), pelvis, shoulders, posterior vertebral spine below L5, in selected cases ribs and sternum
  • Target lesion maximum dimension ≤ 8cm
  • Intended target volume visible by non-contrast MR imaging
  • Distance between target and skin ≥ 1cm
  • Numeric Rating Scale (NRS) score >= 4 or equivalent
  • Life expectancy >3 months

Who cannot join

  • Planned treatment lesion is a primary bone tumor or due to lymphoma, multiple myeloma, or leukemia.
  • Communication barrier present
  • Patient enrolled in another clinical study related to bone metastases treatment or pain relief treatment
  • Unable to tolerate required stationary position during treatment despite adequate pain medication
  • Need for surgery
  • Pregnant woman
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  • Pain related to target lesion is predominantly due to fracture or impending fracture
  • Pain related to target lesion is due to involvement of a neighboring major nerve by the metastatic tumor (cord or nerve compression)
  • Target < 3cm from bladder / bowel / nerve along the beam path and < 1cm in the plane orthogonal to the beam
  • Target in contact with hollow viscera
  • Target located in skull, joints, ribs (when HIFU beam overlapping with lung), spine (excluding sacrum which is allowed) or in most cases sternum
  • Internal or external fixation device along the proposed HIFU beam path or at the target
  • MRI contraindicated (e.g. paramagnetic implants, pacemaker, claustrophobia)
  • MRI contrast agent contraindicated (e.g. previous anaphylaxis or Glomerular Filtration Rate < 20 ml/min/1.73m2)
  • Sedation contraindicated
  • Previous surgery or minimally invasive treatment at targeted site within the last three months
  • Clinically relevant medical history or abnormal physical findings that could interfere with the safety of the participant as judged by the treating physician or investigator
  • Karnofsky performance score (KPS) < 60%
  • Oligometastatic disease planned for curative treatment
  • Indication for stereotactic radiotherapy (e.g. patients with radioresistant histology such as renal cell, melanoma, sarcoma metastases)
  • History of photodermatoses (of the skin overlying the target area)
  • Need for remineralisation

Trial locations and contacts

2 sites in 1 country.

Netherlands2 sites

  • University Medical Center Utrecht

    Utrecht, 3508GA

  • Isala Klinieken Zwolle

    Zwolle, Overijsel, 8025 AB

Other trials in Netherlands

About this study

Official title: Feasibility of Combined Focused Ultrasound and Radiotherapy Treatment in Patients With Painful Bone Metastasis - the PRE-FURTHER Study -

The PRE-FURTHER study aims to evaluate the feasibility of the combined treatment with radiotherapy and focussed ultrasound for pain palliation in patients with painful bone metastases, and to optimize the combined treatment logistics. Six to ten patients will be included according to in- and exclusion criteria.

Read the detailed description

Rationale: Metastatic bone pain strongly interferes with quality of life and daily functioning of patients with advanced cancer. Pain palliation may be improved by including magnetic resonance image guided high intensity focused ultrasound (MR-HIFU) in addition to External Beam Radiotherapy (EBRT). For this purpose, feasibility and optimal logistics of the combined treatment need to be evaluated.

Objective: The PRE-FURTHER project aims to evaluate the feasibility of the combined EBRT and MR-HIFU treatment for relief of metastatic bone pain, and to optimize the combined treatment logistics.

Study design: The PRE-FURTHER study is a prospective case series, stage I and IIA study according to the Innovation, Development, Evaluation, Assessment and Long term evaluation (IDEAL) recommendations. 6-10 patients will receive MR-HIFU treatment following standard EBRT.

Endpoints: The main outcome of this study is the feasibility of the procedure, in terms of planability as well as patient-tolerability of the combined treatment within a short time frame (3 hours - 4 days interval). In addition, pain relief and safety of the combined procedure will be monitored.

Being tested
combined radiotherapy and MR-HIFU
Keywords
Bone metastases, Cancer Induced Bone Pain, Pain palliation, Radiotherapy, Radiation oncology, MR-HIFU, MRI-guided high intensity focused ultrasound, Focused ultrasound, HIFU
Medical subject headings
Bone Neoplasms, Pain, Radiation Injuries, Neoplasms, Neoplasm Metastasis

What participants receive

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

  • combined radiotherapy and MR-HIFUCombination product

    Following standard EBRT (single or multiple fraction), patients will receive one MR-HIFU treatment with the Profound Sonalleve MR-HIFU device on the most painful of their bone metastases. This treatment will take place in a short time frame of 3 hours to maximum 4 days. Patients will be followed up until 4 weeks after treatment. During follow-up they will be phoned around day 3, 7, 14, 21 and 28 to retrieve pain scores, pain medication and (serious) adverse events. At day 3 the patient's experience with the combined treatment will also be inquired.

Study groups in NCT04310410
Study groupRoleWhat they receive
Combined Focused Ultrasound and RadiotherapyExperimentalCombination of focused ultrasound and external beam radiotherapy
Receives: Combination Product: combined radiotherapy and MR-HIFU

What is being measured

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

  1. Feasibility of combined treatment with EBRT and MR-HIFU - Patient tolerance: questionnaire

    The main outcome of this study is the feasibility of the combined procedure in terms of patient tolerance and hospital logistics. Patient tolerance will be assessed using a Patient Reported Experience Measure questionnaire.

    Measured: 4 weeks

  2. Feasibility of combined treatment with EBRT and MR-HIFU - hospital logistics

    The main outcome of this study is the feasibility of the combined procedure in terms of patient tolerance and hospital logistics. Hospital logistics will be assessed by analysing comments of the treating physicians and research staff on the problems that occurred during treatment planning, and whether extra hospital visits that were needed.

    Measured: 4 weeks

Secondary outcomes (2)

  1. Patient reported pain scores.

    Patient reported pain scores will be based on a Numeric Rating Scale (from 0 to 10 with 0 being no pain and 10 being the worst pain imaginable) from the Brief Pain Inventory (BPI) questionnaire [Cleeland 1994].

    Measured: at 3 days, and at 1, 2, 3 and 4 weeks

  2. (Serious) adverse events

    Toxicity/safety of the combined treatment will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

    Measured: at 3 days, and at 1, 2, 3 and 4 weeks

Timeline

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

  1. First posted17 Mar 2020
  2. Study start11 Apr 2019
  3. Primary completion1 Apr 2020
  4. Study completion1 Jun 2020

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 1/2
Primary purpose
Other
Allocation
Not applicable
Intervention model
Sequential
Model description
Prospective case series (n = 6 - 10), stage I and IIA study according to the Innovation, Development, Evaluation, Assessment and Long term evaluation (IDEAL) recommendations. The study will be performed in male and female adult (≥ 18 years) cancer patients capable of giving informed consent and referred for EBRT of painful bone metastases (Numerical Rating Scale (NRS) ≥ 4).
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04310410
Sponsor's protocol ID
NL68441.041.19
Acronym
PRE-FURTHER
Status last verified
Feb 2024
First submitted
24 Sep 2019
Last updated
7 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing combined radiotherapy and MR-HIFU in people with Bone Metastases and Bone Neoplasm, run by UMC Utrecht at 2 sites in Netherlands.

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 14 inclusion and 22 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 7 Feb 2024. 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 Netherlands. 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?

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?

Feasibility of combined treatment with EBRT and MR-HIFU - Patient tolerance: questionnaire (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 NCT04310410.

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 7 Feb 2024.

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