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Safety and Feasibility of MR-Guided High Intensity Focused Ultrasound (MR-HIFU) Ablation of Osteoid Osteoma in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02349971
Recruitment Status : Active, not recruiting
First Posted : January 29, 2015
Last Update Posted : November 27, 2019
Sponsor:
Information provided by (Responsible Party):
Karun Sharma MD, Children's National Research Institute

Tracking Information
First Submitted Date  ICMJE January 15, 2015
First Posted Date  ICMJE January 29, 2015
Last Update Posted Date November 27, 2019
Actual Study Start Date  ICMJE January 2015
Estimated Primary Completion Date October 3, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2015)
Safety and feasibility measured by the number of patients who are able to be treated with MR HIFU and do not experience significant treatment related adverse events. [ Time Frame: 12 months ]
Safety and feasibility will be measured by the number of patients who are able to be treated with MR HIFU and do not experience significant treatment related adverse events.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2015)
Response [ Time Frame: 12 months ]
Provide an assessment of MR-HIFU ablation of OO in children by the number of patients who experience a measurable clinical and imaging response.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Feasibility of MR-Guided High Intensity Focused Ultrasound (MR-HIFU) Ablation of Osteoid Osteoma in Children
Official Title  ICMJE Safety and Feasibility of MR-Guided High Intensity Focused Ultrasound (MR-HIFU) Ablation of Osteoid Osteoma in Children
Brief Summary This study looks to examine the feasibility and efficacy of using MR-HIFU to ablate Osteoid Osteoma lesions in children and young adults.
Detailed Description

Osteoid Osteoma (OO) is a benign, but painful, bone tumor commonly occurring in children and young adults. Common treatment options are surgical excision or, more recently, CT-guided radiofrequency ablation (RFA). RFA is less invasive, but it still requires drilling from the skin through muscle and soft tissue into bone. It also exposes the patient and operator to ionizing radiation.

Magnetic Resonance guided High Intensity Focused Ultrasound (MR-HIFU) provides precise and controlled delivery of focused ultrasound energy inside a lesion using an external applicator, without the need for a scalpel or needle. MR-HIFU has been successfully used to treat painful bone metastases in adult clinical trials and one recent report suggests that it can also be used to treat OO.

MR-HIFU ablation of OO may provide a better alternative to surgical resection or RFA as it is completely non-invasive and does not require ionizing radiation. These two qualities of MR-HIFU are especially beneficial in growing children and young adults. Furthermore, MR-HIFU OO ablation is quick, with expected total procedure time of less than two hours. Such short treatments offer additional safety benefits from reduced anesthesia / sedation requirement compared to surgery and RFA

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Osteoid Osteoma
Intervention  ICMJE Device: MR-HIFU
Magnetic Resonance guided High Intensity Focused Ultrasound (MR-HIFU) provides precise and controlled delivery of focused ultrasound energy inside a lesion using an external applicator, without the need for a scalpel or needle
Study Arms  ICMJE Experimental: All Patients
Patients will undergo a one-time procedure of MR-HIFU ablation of OO under sedation or anesthesia. Patients will be monitored for disease status and adverse events for at least 12 months following procedure.
Intervention: Device: MR-HIFU
Publications * Sharma KV, Yarmolenko PS, Celik H, Eranki A, Partanen A, Smitthimedhin A, Kim A, Oetgen M, Santos D, Patel J, Kim P. Comparison of Noninvasive High-Intensity Focused Ultrasound with Radiofrequency Ablation of Osteoid Osteoma. J Pediatr. 2017 Nov;190:222-228.e1. doi: 10.1016/j.jpeds.2017.06.046. Epub 2017 Aug 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 20, 2018)
9
Original Estimated Enrollment  ICMJE
 (submitted: January 28, 2015)
14
Estimated Study Completion Date  ICMJE October 3, 2020
Estimated Primary Completion Date October 3, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis:

    • All patients with a clinical suspicion of OO based on presence of typical symptoms of localized nocturnal pain that is relieved by NSAIDs and unrelated to trauma or activity.
    • Typical imaging findings on CT and/or MRI. Plain radiographs and bone scans may be obtained by referring physicians and are helpful for confirming the clinical diagnosis but cannot be substituted for a CT or MRI.
    • Non-contrast enhanced or contrast enhanced CT studies are acceptable.
    • Contrast enhanced MRI studies should be performed.
    • Tissue biopsy is not required
  • Tumor location:

    • Target lesions can be located in any peripheral bone with acoustic accessibility.
    • Target lesions may be intracortical or juxtacortical in location.
    • Target lesions must be reachable within the normal safety margins of HIFU as specified in the instructions for use.
  • Prior therapy:

    ●Patients with prior unsuccessful surgical resection or RFA are eligible for enrollment.

  • Laboratory :

    • Hemoglobin > 9 g/dL
    • Platelet count ≥75,000/µL (may receive transfusions)
    • Normal PT, PTT and INR < 1.5 x ULN (including patients on prophylactic anticoagulation)
    • Renal function: Age-adjusted normal serum creatinine (table in protocol) OR a creatinine clearance ≥60 mL/min/1.73 m2 for safe contrast administration
  • Adequate pulmonary function: Defined as no dyspnea at rest, and a pulse oximetry >94% on room air if there is clinical indication for determination.

Exclusion Criteria:

  • Clinically significant unrelated systemic illness, such as serious infections, hepatic, renal or other organ dysfunction, which in the judgment of the Principal or Associate Investigator would compromise the patient's ability to tolerate the general anesthetic required for the procedure.
  • Implant or prosthesis or scar tissue within the path of the HIFU beam.
  • Target <1 cm from nerve plexus, spinal canal, bladder, bowel
  • Target <1 cm of the growth plate (physis)
  • Lesion in the skull or vertebral body
  • Inability to undergo MRI and/or contraindication for MRI
  • Inability to tolerate stationary position during HIFU
  • Patients currently receiving any investigational agents.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 25 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02349971
Other Study ID Numbers  ICMJE HIFU OO
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Karun Sharma MD, Children's National Research Institute
Study Sponsor  ICMJE Children's National Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Karun Sharma, MD, PhD Children's National Research Institute
PRS Account Children's National Research Institute
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP