Symptoms and General Pathology

All Conditions

Neoplasms

Heart and Blood Diseases

Neovascularization, Pathologic

Osteoma

Neoplasms, Vascular Tissue

Vascular Neoplasms

Osteoma, Osteoid

Metaplasia

Romain GILLET, MD

To evaluate the image quality and ability to depict in vivo bone vascularization with an ultra-high-resolution computed tomography (UHR-CT) scanner using a deep learning reconstruction (DLR) and hybrid iterative reconstruction (HIR) algorithms, compared to simulated conventional CT, using osteoid osteoma (OO) as a model.

In Vivo Depiction Of Bone Vascularization With UHR-CT CT And Deep Learning Algorithm Reconstruction: A Preliminary Study

Central Hospital, Nancy, France

MD, MSK Radiologist

Skin and Connective Tissue Diseases

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

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.

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

Karun Sharma, MD, PhD

This study looks to examine the feasibility and efficacy of using MR-HIFU to ablate Osteoid Osteoma lesions in children and young adults.

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

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

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.

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

Children's National Research Institute

Magnetic resonance-guided focused ultrasound ablation

Computed tomography-guided radiofrequency ablation

Magnetic resonance-guided focused ultrasound ablation of osteoid osteoma

MRgFUS

Computed tomography-guided radiofrequency ablation of osteoid osteoma

CTgRFA

Maya Aslam

Krithika Rupnarayan

Pejman Ghanouni, MD, PhD

Matthew Bucknor, MD

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.

Comparative Effectiveness of MRgFUS Versus CTgRFA for Osteoid Osteomas

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

1 month after treatment, worst VAS score over the last 24 hours will be assessed

On the day of the treatment, the procedure time will be recorded

2 weeks after treatment, patient preference surveys will be assessed

1 month after treatment, patient quality of life surveys will be assessed

Self reported medication use for 5 days before, five days after, and 1 month after the treatment

All adverse events occurring within the first month will be recorded at 1 month following the procedure

Worst VAS over the last 24 hours will be assessed for each of the first 5 days following the treatment and then at 1 week, 2 weeks, 3 weeks, 1 month, 6 months, and 12 months following the treatment

Focused Ultrasound Foundation

Matthew Bucknor

Assistant Professor in Residence

Pain

Patients will undergo MR-HIFU ablation procedure of OO under general anesthesia. Patients will be monitored for disease status and adverse events for 12 months following procedure. Patients with incomplete or partial response at 28 days after MR-HIFU will be permitted a second MR-HIFU procedure.

If there is still incomplete pain relief without medication use by 28 days following the second MR-HIFU treatment, patients will be offered standard of care treatment with RFA and followed for one year.

MR-HIFU is an innovative technology that allows for non-invasive thermal ablation of tissues and tumors by integrating an external high intensity focused ultrasound (HIFU) transducer with a conventional MRI scanner.

The focused ultrasound transducer is placed outside of the body and generates and focuses acoustic energy to heat tumors or other pre-defined focal regions of tissues inside the body. Because the acoustic energy is precisely focused over tiny areas of tissue, potential thermal injury to surrounding tissues is minimal. Cell death inside the selected treatment area occurs via coagulative necrosis while avoiding injury to intervening and adjacent tissues.

MR-HIFU treatment

To determine treatment safety and efficacy of MR-HIFU ablation of painful Osteoid Osteoma (OO) in children and young adults.

Osteoid Osteoma (OO) is a benign, but painful, bone tumor commonly occurring in children and young adults. Definitive treatment options are CT-guided radiofrequency ablation (RFA) and less commonly, open surgical resection. RFA is less invasive than surgery, but it still requires drilling from the skin through muscle and 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 any incisions or drilling. MR-HIFU has been successfully used to treat painful bone metastases in adult clinical trials. Several recent reports, including two publications from our group, show that MR-HIFU is a feasible and safe treatment for 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.

The investigator's group has performed the first pilot clinical trial in the U.S. to evaluate MR-HIFU treatment for painful osteoid osteoma (PI: K.V. Sharma, NCT02349971). This trial shows that MR-HIFU ablation is feasible, well tolerated, and can be safely performed in a pediatric cohort. Based on these results, the investigators propose a pivotal clinical trial designed to evaluate treatment efficacy as the next logical step required for clinical translation. The investigators hypothesize that noninvasive and radiation-free MR-HIFU ablation for osteoid osteoma will be a clinically effective treatment, with success rate comparable to that currently reported for RFA.

MR-HIFU Treatment of Painful Osteoid Osteoma

Pivotal / Phase II Clinical Trial of Magnetic Resonance-Guided Focused Ultrasound (MR-HIFU) Treatment of Painful Osteoid Osteoma in Children and Young Adults

The patient pain and medication diary will be used

The VAS is a continuous numerical pain scale ranging from 0 (no pain) to 10 (worst possible pain)

The PROMIS Pain Interference Short Form consists of 8 questions on pain. Each question will be rated from 0 (never), 1 (almost never), 2 (sometimes), 3 (often), and 4 (almost always)

The PedsQL is a 23-item, 4 scale, and 2 domain instrument measuring physical, social, emotional, and cognitive well-being. Each question will be rated from 0 (never) to 4 (almost always)

SDS is a 10-item Likert format instrument that measures symptom intensity and distress. Each question will be rated from 1 (no problems in the area) to 5 (worst problems in this area)

Number of participants with change in nidus size (mm) as assessed via MRI

Number of participants with change in nidus vascularity as assessed via MRI

Number of participants with changes in soft tissue and marrow edema as assessed via MRI

Director of Interventional Radiology

Musculoskeletal Diseases

Bone Neoplasms

MR guided High Intensity focused ultrasound

High Intensity Focused Ultrasound is a totally non-invasive procedure that can destroy tumors transcutaneously; safety and efficacy profile are dramatically increased by the MRI guidance

Alessandro Napoli, MD, PhD

Alessandro Napoli

Alessandro napoli, MD, PhD

Non-invasive treatment of Osteoid osteoma using MRI guided high-intensity focused ultrasound. This study is designed as an intention-to-treat using a totally non-invasive approach for pain reduction, quality of life improvement and long-term bone restoration. Procedure is performed in a single session using limited amount of acoustic energy to target the osteoid nidus. Treatment will be performed under anesthesia (peripheral or general according to age and lesion position).

An osteoid osteoma is a benign, painful musculoskeletal tumor that usually occurs in young males. The standard of care in the United States is computed tomography (CT)-guided radiofrequency ablation, a minimally invasive percutaneous procedure, with clinical success rates ranging between 85% and 98%.

Percutaneous or surgical therapy can lead to non-negligible side-effects and limited efficacy for pediatric population or young adults with osteoid osteoma. We investigate whether selective focal ablation of osteoid lesions can reduce this treatment burden without compromising long-term clinical efficacy.

Treatments will be performed using a 3.0-T MR unit (Discovery MR 750; GE Medical Systems, Milwaukee,Wis) featuring a Conformité Européenne-approved ExAblate MR-guided focused ultrasound system (InSightec,Tirat-Carmel, Israel) in which the ultrasound transducer is housed in the patient table. Alignment between the lesion and the transducer will be obtained in each patient by using a moistened gel pad and degassed water for acoustic coupling. This approach avoided air- skin interfaces, which can cause energy reflection and skin burns. After patient positioning, the lesion is localized with MR for treatment by using variably orientated non enhanced T1- and T2-weighted acquisitions. In general, an ideal 90° incidental angle between the planned focused ultrasound path and the lesion, relative to the bone long axis, is obtained or at least approximated. The shortest skin-lesion distance is selected for the beam pathway. Care will be taken to avoid multiple interfaces (skin, muscle, fasciae) as much as possible so as to minimize deflection of the focused ultrasound beam. Each lesion will be manually segmented by the operator to precisely delineate the nidus, skin surface, and cortical surface of the bone. Sensitive areas surrounding the target volumes will also be drawn to limit the energy and prevent unwanted thermal damage. The treatment plan is than calculated automatically by the ExAblate software according to previously acquired parameters, including the energy (in joules), the interval between two sonications, the sonication duration, and the spot size, which are modifiable by the operator. Thereafter, a low-energy sonication test will be performed to confirm the path and correct direction of the ultrasound beam into the target area and to confirm the planned energy dose and the effective dose deployed to the lesion.

The increase in tissue temperature is evaluated by using real-time MR thermometry of phase-difference fast spoiled gradient-echo sequences (proton resonant frequency shift method). The sequences are acquired to provide temperature-dependent images and real-time mapping of the thermal dose on a preferred imaging plane. The proton resonant frequency shift method starts simultaneously with each sonication. Similar to other treatments of bone lesions that use MR-guided focused ultrasound, the temperature increase is determined on the adjacent periskeletal tissue. In fact, proton resonant frequency sequences cannot effectively measure the temperature on the bone surface because of the absence of moving protons in the cortical zone. Thus, MR thermometry reveals a temperature increase, which propagates by conductive processes from the bone to the immediately adjacent soft tissues that respond linearly to an increase in bone temperature, thereby allowing an accurate measure of heating. Portions of periosteum and adjacent tumor that are not fully ablated can be re-treated if deemed necessary. The critical temperature threshold for ablation is set at 65°C in the soft tissues adjacent to the targeted bone structures. Postprocedural care includes evaluation of possible skin burns, monitoring of vital signs for 2 hours after treatment in the MR department, and administration of analgesic and/or antiemetic drugs if requested. Treatment-related adverse events will be recorded as minor or major on the basis of medical severity, additional treatment, and long-term consequences for patients. Treatment will be performed on an outpatient basis in the patients who receive only local and peripheral anesthesia; the patient who receives general anesthesia is usually hospitalized for 24 hours after treatment.

Non-invasive Focal Therapy for Osteoid Osteoma

Treatment of Osteoid Osteoma With MR Guided High Intensity Focused Ultrasound

correlation between nidus vascularization reduction and symptoms relieve

University of Roma La Sapienza

MD, PhD

Blood and Lymph Conditions

Neoplasm Metastasis

Bone Marrow Diseases

Neoplastic Processes

Bone Diseases

Hematologic Diseases

The transducer is maintained by a flexible/rigid structure, consisting of a support base, and three to four feet forming an arch around the area to be treated. These feet exist in several lengths (10, 20, 30, 40 cm) depending on the area to be treated and can be easily mounted on the base by fast attachment. The structure is based on the principle of granular jamming: it is flexible in its normal state, and can be stiffened by the application of depression within the feet.

UFOGUIDE "patient transducer"

Afshin GANGI, Pr

Ufoguide is a prospective single arm open study to assess the feasibility of a new type of HIFU system to treat bone tumors.

HIFU is classically delivered by a transducer integrated in the MRI table. This study assesses a new type of approach in which the HIFU transducer is manually placed on the skin of the patient, under the assistance of optical navigation, and held in place by MR-compatible passive arms.

The primary goal of this study is to assess the feasibility of heating the tumor accurately with this new HIFU system. The evaluation and monitoring of the treatment will be performed by MR thermometry.

Secondary endpoints include the evaluation of clinical efficacy, quality of life and safety.

Ufoguide is a prospective single arm open study to assess the feasibility of a new type of HIFU system for the treatment of painful metastases (palliative intent) and osteoid osteoma (curative intent).

HIFU is classically delivered by a transducer integrated in the MRI table. This study assesses a new type of approach in which the HIFU transducer is manually placed on the skin of the patient and held in place by MR-compatible passive arms. Optical infrared navigation is used to help the physician with the positioning of the HIFU transducer.

The primary goal of this study is to assess the feasibility of heating the tumor accurately with this new HIFU system. The evaluation and control of the treatment will be performed by Proton Resonance Frequency Shift (PRFS) MR thermometry.

Secondary endpoints include the evaluation of clinical efficacy, quality of life and safety.

Clinical efficacy is defined:

* in palliative intent by a decrease ≤3 on visual analogic scale
* in curative intent (osteoid osteoma) by a total disappearance of pain Quality of life is assessed by EORTC quality of life questionnaire-core 30 items Complications are recorded to assess safety.

MRI-guided Focused Ultrasound : Feasibility Study for the Treatment of Bone Metastases and osteoïd Osteoma

MRI-guided Focused Ultrasound for Bone Tumors Treatment: Feasibility Study for the Treatment of Bone Metastases and osteoïd Osteoma

The device feasibility is defined by the ability of the device to induce a hyperthermia on the tumor

Clinical efficacy is defined:

* in palliative intent by a decrease ≤3 on visual analogic scale
* in curative intent (osteoid osteoma) by a total disappearance in pain

EORTC quality of life questionnaire is composed of multi-items scales and single-item measures. All of the scales measures range in score from 0 to 100. A High scale score represents a higher response level.

University Hospital, Strasbourg, France

patients with osteoid osteoma at any location

surgery for osteoid osteoma: this may include curettage or en-bloc resection of the lesion

surgical removal of osteoid osteoma

Purpose of the study:

To retrospectively determine the clinical results in an unselected group of consecutive patients with osteoid osteoma treated by surgery.

Materials and Methods:

In 150 consecutive patients with clinical and/or radiological evidence for osteoid osteoma at any location, the clinical symptoms and imaging findings (radiographs and computed tomography (CT)) were assessed before and after surgery. There were no exclusion criteria for this study. A good response was defined as disappearance of symptoms that were manifested at presentation and were attributed to osteoid osteoma. Clinical assessment after the procedure was performed prior to discharge; within 2 weeks after the procedure; and at 3, 6, and 12 months follow-up. After 24 months, a postal questionnaire was used for assessment. Radiographic evaluation (radiographs and thin-slice CT) was performed routinely pre-operatively and one year after surgery.

In case of persisting or recurring symptoms the follow-up protocol was again performed according to the initial protocol.

All patients gave their informed consent both for the surgical intervention as for the use of their patient data in this retrospective study.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
In Vivo Depiction Of Bone Vascularization With UHR-CT CT And Deep Learning Algorithm Reconstruction: A Preliminary Study	NCT05628792	Bone Vascular T...	CT	18 Years - 70 Years	Central Hospital, Nancy, France
Safety and Feasibility of MR-Guided High Intensity Focused Ultrasound (MR-HIFU) Ablation of Osteoid Osteoma in Children	NCT02349971	Osteoid Osteoma	MR-HIFU	- 25 Years	Children's National Research Institute
Comparative Effectiveness of MRgFUS Versus CTgRFA for Osteoid Osteomas	NCT02923011	Osteoid Osteoma	MRgFUS CTgRFA	8 Years -	University of California, San Francisco
MR-HIFU Treatment of Painful Osteoid Osteoma	NCT04658771	Osteoid Osteoma	MR-HIFU treatme...	0 Years - 30 Years	Children's National Research Institute
Non-invasive Focal Therapy for Osteoid Osteoma	NCT02302651	Osteoma, Osteoi...	MR guided High ...	3 Years - 80 Years	University of Roma La Sapienza
MRI-guided Focused Ultrasound : Feasibility Study for the Treatment of Bone Metastases and osteoïd Osteoma	NCT04803773	Painful Bone Me... Superficial Ost...	UFOGUIDE "patie...	18 Years -	University Hospital, Strasbourg, France
Treatment Outcome After Surgical Treatment of Osteoid Osteoma	NCT01466010	Osteoid Osteoma	surgical remova...	2 Years - 70 Years	Universitaire Ziekenhuizen KU Leuven

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