MR Guided Focused Ultrasound vs Radiotherapy for Palliative Pain Tx in Bone Metastases
Trial ID or NCT#
NCT05250687
Status
NOT RECRUITING
Purpose
This is a prospective, single-center, randomized study directly comparing outcomes after MR guided high intensity focused ultrasound (MR HIFU) or external beam radiation therapy (EBRT) treatment of painful bone metastases.
Official Title
MR Guided Focused Ultrasound Versus Radiotherapy for Palliative Pain Treatment in Patients With Bone Metastases
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
- 1. Age ≥ 18 years2. Painful metastatic bone lesions, with NRS \> 4 documented at screening visit3. Pain from target lesion is distinguishable from other lesions\*4. Target lesion lovation is accessible for MR-HIFU and EBRT\*\*5. Target lesion is visible om MR or CT imaging obtained \< 3 months prior to screening, with a maximum diameter of 8 cm.6. Reasonable performance score (KPS \> 50% or ECOG \<3)7. Life expectancy \> 3 months as determined by the study PI or referring oncologist8. Ability to understand and the willingness to personally sign the written IRB-approved informed consent document
- * Solitary painful metastatic bone lesion or multiple metastatic lesions with one predominantly painful target lesion (≥2 points higher pain score than other lesions).
- * e.g.: Extremities, pelvis (os pubis, os ilium, os ischium, sacrum, acetabulum), shoulders, in selected cases ribs and sternum
Exclusion Criteria:
- 1. Previous surgery, radiation, HIFU, or other local therapy on the target location2. Neurological symptoms due to nerve involvement of target lesion3. Need for surgery of targeted location due to (impending) pathological fracture4. Unavoidable critical structures or dense tissues in target area\*5. Curative intention of treatment plan6. Patients with contraindication for MR imaging such as implanted metallic devices that are not MRI - safe, size limitations, claustrophobia, etc.7. Patients with known intolerance or allergy to MR contrast agent (gadolinium chelates) including advanced kidney disease (GFR \<30mL/min/1.73 m\^2) or on dialysis8. Pregnant and nursing patients will be excluded from the study because of a contraindication to administering MRI contrast agents to these patients9. Patients unable to receive general anesthesia, as determinded by anesthesiologist, study PI or referring oncologist10. Individuals who are not able or willing to tolerate the required prolonged stationary position during treatment (can be up to 4 hrs of total table time) via self report11. Participant enrolled in another clinical interventional study related to bone metastases treatment or pain relief treatment12. Clinically relevant medical history or physical findings that could interfere with the patient's safety as judged by the treating physician
- * as judged by the operator. e.g.: nerve bundles, skin, extensive scarring, non-targeted bones, air (e.g. hollow viscera), (external) fixation device
Investigator(s)
Pejman Ghanouni, MD, PhD
Radiologist
Associate Professor of Radiology (Body MRI) and, by courtesy, of Neurosurgery, of Obstetrics and Gynecology and of Urology
Lucas Kas Vitzthum, MD
Radiation oncologist
Clinical Associate Professor, Radiation Oncology - Radiation Therapy
Contact us to find out if this trial is right for you.
Contact
Brittney Williams
650-497-8588
View on