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

Primary Purpose

Osteoid Osteoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MR-HIFU
Sponsored by
Children's National Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoid Osteoma

Eligibility Criteria

undefined - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Children's National Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All Patients

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Response
Provide an assessment of MR-HIFU ablation of OO in children by the number of patients who experience a measurable clinical and imaging response.

Full Information

First Posted
January 15, 2015
Last Updated
March 9, 2022
Sponsor
Children's National Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02349971
Brief Title
Safety and Feasibility of MR-Guided High Intensity Focused Ultrasound (MR-HIFU) Ablation of Osteoid Osteoma in Children
Official Title
Safety and Feasibility of MR-Guided High Intensity Focused Ultrasound (MR-HIFU) Ablation of Osteoid Osteoma in Children
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
October 3, 2020 (Actual)
Study Completion Date
October 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's National Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoid Osteoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All Patients
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
MR-HIFU
Intervention Description
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
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Response
Description
Provide an assessment of MR-HIFU ablation of OO in children by the number of patients who experience a measurable clinical and imaging response.
Time Frame
12 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karun Sharma, MD, PhD
Organizational Affiliation
Children's National Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's National Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20012
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28823554
Citation
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.
Results Reference
derived

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

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