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Feasibility of Combined Focused Ultrasound and Radiotherapy Treatment in Patients With Painful Bone Metastasis | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

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

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

NCT04310410•UMC Utrecht

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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
+4 more criteria

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
+12 more criteria

Locations (2)

Isala Klinieken Zwolle

Zwolle, Overijsel, Netherlands

University Medical Center Utrecht

Utrecht, Netherlands

Key Dates

Start Date

April 11, 2019

Primary Completion Date

April 1, 2020

Completion Date

June 1, 2020

Last Updated

February 7, 2024

Enrollment

ACTUAL participants

Conditions

Bone MetastasesBone NeoplasmBone LesionBone CancerPainCancer Induced Bone PainRadiation ToxicityQuality of LifeTumorNeoplasm Metastasis

Interventions

combined radiotherapy and MR-HIFU

COMBINATION_PRODUCT

Simulation-Free, Single-Fraction Palliative Radiation Therapy for Treatment of Bone Metastases

NCT07202273

Bone Metastases

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RECRUITINGNA

SFRT and SCART in Radiotherapy for Bone Metastases With Soft Tissue

NCT06987370

Bone Metastases in Subjects With Advanced Cancer

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ENROLLING_BY_INVITATIONNA

EXercise Enhancement After RadioTherapy for Bone Metastases

NCT06470503

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 7, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Simulation-Free, Single-Fraction Palliative Radiation Therapy for Treatment of Bone Metastases

SFRT and SCART in Radiotherapy for Bone Metastases With Soft Tissue

EXercise Enhancement After RadioTherapy for Bone Metastases

Focused Ultrasound and RadioTHERapy for Noninvasive Palliative Pain Treatment in Patients With Bone Metastases

Supervised Exercise in Improving Physical Fitness Before Surgery in Patients With Resectable Bone Cancer

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