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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

April 11, 2019

Primary Completion Date

April 1, 2020

Study Completion Date

June 1, 2020

Conditions
Bone MetastasesBone NeoplasmBone LesionBone CancerPainCancer Induced Bone PainRadiation ToxicityQuality of LifeTumorNeoplasm 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.

Trial Locations (2)

8025 AB

Isala Klinieken Zwolle, Zwolle

3508GA

University Medical Center Utrecht, Utrecht

All Listed Sponsors
collaborator

Isala

OTHER

lead

UMC Utrecht

OTHER

NCT04310410 - Feasibility of Combined Focused Ultrasound and Radiotherapy Treatment in Patients With Painful Bone Metastasis | Biotech Hunter | Biotech Hunter