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

NCT04310410 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-02-07

No results posted yet for this study

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.

Conditions

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

Interventions

COMBINATION_PRODUCT

combined radiotherapy and MR-HIFU

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.

Sponsors & Collaborators

  • Isala

    collaborator OTHER

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • Helena M Verkooijen, MD, PhD · UMC Utrecht

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-11
Primary Completion
2020-04-01
Completion
2020-06-01

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04310410 on ClinicalTrials.gov