RECRUITING

Comparative Effectiveness of MRgFUS Versus CTgRFA for Osteoid Osteomas

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Conditions

Osteoid Osteoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Osteoid osteomas are painful, benign bone tumors that occur most frequently in young males between ages 10 and 20 years. The goal of the proposed study is based on the premise that MRgFUS is noninferior to CT-guided radiofrequency ablation (CTgRFA), in terms of pain reduction following treatment of osteoid osteomas, and offers possible improvements with regards to 1) post-procedural pain, 2) clinical resource utilization, 3) patient experience, and/or 4) adverse events. The data from the current study would provide clinicians important information in deciding between treatment options for ablation of osteoid osteomas.

Official Title

Phase III Study to Compare the Effectiveness of Magnetic Resonance Guided Focused Ultrasound With Computed Tomography Guided Radiofrequency Ablation for Treatment of Osteoid Osteomas

Quick Facts

Study Start:2017-03-28
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02923011

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:8 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Men and women ages ≥ 8 years old.
  2. 2. Diagnosis of osteoid osteoma as confirmed when a musculoskeletal radiologist and orthopedic oncologist agree that a patient's imaging and clinical history are most compatible with the diagnosis of osteoid osteoma. A patient referred by a clinician other than orthopedic oncologist will require a clinic visit with an orthopedic oncologist for study inclusion.
  3. 3. Patients must have medically uncontrolled pain from an osteoid osteoma, as defined by pain, which, in the view of the referring orthopedic oncologist significantly interferes with that patient's activities of daily living. Pain may be refractory to management with medications because of inadequate pain control, or because of side effects of the pain medication.
  4. 4. If patients have an additional site of pain, it must be 2 points less severe and distinguishable from the pain at the osteoid osteoma site.
  5. 5. Patients (or guardians/parents) who are able and willing to give consent (or assent where applicable) and able to attend all study visits.
  6. 6. No prior interventional therapy for the osteoid osteoma.
  7. 7. Able to safely undergo MRI exam, tolerate being in an MRI scanner, and receive anesthesia/sedation for the treatment.
  8. 8. Targeted bone/tumor interface is accessible to the ExAblate device and located in a rib, extremity (excluding intra-articular location), pelvis, shoulders (including clavicles), or the sternum.
  9. 9. Targeted lesion must be deeper than 1 cm from the skin.
  10. 10. Targeted lesion must be clearly visible by non-contrast MRI.
  11. 11. Karnofsky Performance Status \> 60.
  1. 1. Patients a) who need surgical stabilization of the affected bone (elevated fracture risk) or b) whose targeted tumor is at an impending fracture site, as determined by the referring orthopedic oncologist.
  2. 2. Targeted tumor in the skull/spine.
  3. 3. Targeted tumor is \< 1 cm from a major nerve.
  4. 4. Pregnancy.
  5. 5. Patients with an acute medical condition (e.g. pneumonia, sepsis) that is expected to hinder them from completing this study.
  6. 6. Patients with unstable cardiac status including: patients on anti-arrhythmic drugs, unstable angina pectoris, documented myocardial infarction within six months of protocol entry, congestive heart failure requiring medication (other than diuretic).
  7. 7. Severe hypertension (diastolic BP \> 100 on medication)
  8. 8. Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices.
  9. 9. Patients with an active infection or severe hematological, neurological, or other uncontrolled disease.
  10. 10. Severe cerebrovascular disease.
  11. 11. Known intolerance or allergy to medications used for sedation/anesthesia.
  12. 12. Known intolerance or allergy to MR contrast agent (gadolinium chelates).
  13. 13. Patients unable to communicate with the investigator and staff.
  14. 14. Patients with persistent pain undistinguishable from the target lesion.

Contacts and Locations

Study Contact

Maya Aslam
CONTACT
maya.aslam@ucsf.edu

Principal Investigator

Matthew Bucknor, MD
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

Stanford Medical Center
Palo Alto, California, 94305
United States
UCSF Imaging Center
San Francisco, California, 94107
United States

Collaborators and Investigators

Sponsor: Matthew Bucknor

  • Matthew Bucknor, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-03-28
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2017-03-28
Study Completion Date2024-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Osteoid Osteoma