MRI Guided High Intensity Focused Ultrasound (HIFU) and ThermoDox for Palliation of Painful Bone Metastases

Phase II Trial of Phillips MRI-Guided High Intensity Focused Ultrasound (Sonalleve) and Lyso-thermosensitive Liposomal Doxorubicin (ThermoDox) for Palliation of Painful Bone Metastases

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01640847

Enrollment

Registered

2012-07-16

Start date

2012-07-31

Completion date

2013-07-31

Last updated

2017-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenocarcinoma, Breast Carcinoma, Non-small Cell Lung Cancer, Painful Bone Metastases, Small Cell Lung Cancer

Keywords

Painful bone metastases, Bone Cancer, Bone Cancer Pain, Patients with

Brief summary

This study will evaluate treatment with High Intensity Focused Ultrasound (HIFU)in combination with ThermoDox (liposomal doxorubicin) is safe and effective in reducing pain for patients with painful bone metastases.

Interventions

DRUGHigh Intensity Focused Ultrasound (HIFU) in combination with ThermoDox

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Histological confirmation of breast carcinoma, non-small cell lung cancer, small cell lung cancer, or adenocarcinoma of the prostate * Bone metastases index lesion in the ribs, clavicle, scapula, upper extremities, pelvis, or posterior aspects of the lumbar vertebra L3-L5 or sacral S1-S5. * Patients will have failed at least one prior attempt or will not be eligible for external beam radiation therapy (EBRT)

Exclusion criteria

* Greater than 450 mg/m2 of prior free doxorubicin and/or non-heat activated liposomal doxorubicin * LVEF \< 50% * Significant Cardiac History * Brain Metastases * Contraindication for MR imaging (as incompatible implanted metallic device, weight \>250 lbs etc) or known intolerance or allergy to MRI contrast agents.

Design outcomes

Primary

Measure	Time frame
Rate of complete pain response	12 months

Secondary

Measure	Time frame
Adverse Events	3 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026