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Feasibility of Combined Focused Ultrasound and Radiotherapy Treatment in Patients With Painful Bone Metastasis (PRE-FURTHER)

Primary Purpose

Bone Metastases, Bone Neoplasm, Bone Lesion

Status

Unknown status

Phase

Phase 1

Locations

Netherlands

Study Type

Interventional

Intervention

combined radiotherapy and MR-HIFU

About this trial

This is an interventional other trial for Bone Metastases focused on measuring Bone metastases, Cancer Induced Bone Pain, Pain palliation, Radiotherapy, Radiation oncology, MR-HIFU, MRI-guided high intensity focused ultrasound, Focused ultrasound, HIFU

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
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

Exclusion Criteria:

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
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

Sites / Locations

Isala Klinieken ZwolleRecruiting
University Medical Center UtrechtRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Combined Focused Ultrasound and Radiotherapy

Arm Description

Combination of focused ultrasound and external beam radiotherapy

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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].

(Serious) adverse events (CTCAE)

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

Full Information

NCT ID

NCT04310410

First Posted

September 24, 2019

Last Updated

March 16, 2020

Sponsor

UMC Utrecht

Collaborators

Isala

1. Study Identification

Unique Protocol Identification Number

NCT04310410

Brief Title

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

Acronym

PRE-FURTHER

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Unknown status

Study Start Date

April 11, 2019 (Actual)

Primary Completion Date

April 1, 2020 (Anticipated)

Study Completion Date

June 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

UMC Utrecht

Collaborators

Isala

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bone Metastases, Bone Neoplasm, Bone Lesion, Bone Cancer, Pain, Cancer Induced Bone Pain, Radiation Toxicity, Quality of Life, Tumor, Neoplasm Metastasis

Keywords

Bone metastases, Cancer Induced Bone Pain, Pain palliation, Radiotherapy, Radiation oncology, MR-HIFU, MRI-guided high intensity focused ultrasound, Focused ultrasound, HIFU

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1, Phase 2

Interventional Study Model

Sequential Assignment

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)

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Combined Focused Ultrasound and Radiotherapy

Arm Type

Experimental

Arm Description

Combination of focused ultrasound and external beam radiotherapy

Intervention Type

Combination Product

Intervention Name(s)

combined radiotherapy and MR-HIFU

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

4 weeks

Title

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

Description

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Patient reported pain scores.

Description

Time Frame

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

Title

(Serious) adverse events (CTCAE)

Description

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

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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 Exclusion Criteria: 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 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marcia Bartels, MD

Phone

+31 88 75 500 55

m.m.t.bartels-6@umcutrecht.nl

First Name & Middle Initial & Last Name or Official Title & Degree

Helena M Verkooijen, MD, PhD

Phone

+31 88 75 595 75

h.m.verkooijen@umcutrecht.nl

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Helena M Verkooijen, MD, PhD

Organizational Affiliation

UMC Utrecht

Official's Role

Principal Investigator

Facility Information:

Facility Name

Isala Klinieken Zwolle

City

Zwolle

State/Province

Overijsel

ZIP/Postal Code

8025 AB

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Inez M Verpalen, MD

i.m.verpalen@isala.nl

First Name & Middle Initial & Last Name & Degree

Martijn F Boomsma, MD, PhD

Phone

+31 38 424 7202

m.f.boomsma@isala.nl

Facility Name

University Medical Center Utrecht

City

Utrecht

ZIP/Postal Code

3508GA

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Helena M Verkooijen, MD, PhD

h.m.verkooijen@umcutrecht.nl

First Name & Middle Initial & Last Name & Degree

Marcia MT Bartels, MD

m.m.t.bartels-2@umcutrecht.nl

First Name & Middle Initial & Last Name & Degree

Marcia MT Bartels, MD

First Name & Middle Initial & Last Name & Degree

Helena M Verkooijen, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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