Neoplasms

All Conditions

Soft Tissue Neoplasms

Antipyretics

Anti-Inflammatory Agents

Antirheumatic Agents

Fibrinolytic Agents

Analgesics

Platelet Aggregation Inhibitors

All Drugs and Chemicals

Anticoagulants

Aspirin

Enoxaparin

Enoxaparin sodium

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Enzyme Inhibitors

The InSightec ExAblate 2000 magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) system is a non-invasive device that is fully integrated with an MR imaging system and used for the ablation of soft tissue. The treatment process begins with the physician acquiring a set of MR images, identifying 1+ target volume(s) of fibroid tissue to be ablated, and drawing the treatment contours. The therapy planning software computes the type and number of sonications required to treat the defined volume while minimizing total treatment time. MR images taken during the sonication provide a diagnostic quality image of the target tissue and a quantitative, real-time temperature map overlay to confirm the therapeutic effect of the treatment. The transducer is then automatically moved to the succeeding treatment point and the process is repeated until the entire volume has been treated. About 100 individual sonications can be delivered over a 3-hour period to complete a treatment.

The InSightec ExAblate 2000 magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) system is a non-invasive thermal ablation device fully integrated with an MR imaging system and used for the ablation of soft tissue

MRgHIFU

325 mg PO for deep venous thrombosis (DVT) prophylaxis initiated 2 hours prior to magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) treatment

40 mg by subcutaneous (SC) administration, for deep venous thrombosis (DVT) prophylaxis initiated 2 hours prior to magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) treatment

Raffi Avedian, MD

Pejman Ghanouni, MD, PhD

The goal of this project is to evaluate the safety and preliminary efficacy of ExAblate magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) surgery in the treatment of soft tissue tumors of the extremities.

Given that the incidence of cancer increases with age, the number of elderly patients diagnosed and treated for soft tissue sarcomas (STS) will increase. The dilemma is that surgeons and medical oncologists may be hesitant to treat elderly patients in a comparably intensive manner as is used in the treatment of younger patients; factors such as decreased performance status, significant comorbidities, and disease natural history may erode enthusiasm for aggressive STS resection. To this end, a less invasive way of treating soft tissue tumors would be helpful in younger patients to minimize morbidity and in the elderly to provide less aggressive treatment options. The InSightec ExAblate 2000 magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) system is a non-invasive thermal ablation device fully integrated with an MR imaging system and used for the ablation of soft tissue (5-10). The ExAblate combines a focused ultrasound surgery (FUS) delivery system and a conventional diagnostic 1.5 T or 3 T MRI scanner. It provides a real-time therapy planning algorithm, thermal dosimetry, and closed-loop therapy control.

Feasibility of ExAblate MRI Guided High Intensity Focused Ultrasound Tx of Soft Tissue Tumors

A Feasibility Study to Evaluate the Safety and Effectiveness of ExAblate Magnetic Resonance Imaging Guided High Intensity Focused Ultrasound Treatment of Soft Tissue Tumors of the Extremities

Safety determined by evaluating for the incidence of any device-related adverse events. Patients will be assessed for pain and limb function, and by clinical examination before and after treatment to collect adverse events related to the treatment. Safety is reported as the total incidence of device-related adverse events.

Safety is further assessed by an evaluation of severity for the treatment-related adverse events, reported as the number of adverse events for each of the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 grades.

CTCAE Severity:

1. mild
2. moderate
3. severe
4. life-threatening
5. fatal

In the resected tumor specimen, the volume of the ablated area will be determined by obtaining a digital photograph of each pathology slice. The region of interest corresponding to the ablated area will be traced, and the ablated area will be calculated for each slice and summed. Accuracy is assessed as the percent ablated volume relative to pre-treatment tumor volume.

Pejman Ghanouni

Assistant Professor of Radiology

The InSightec ExAblate 2000 MRgHIFU system is a non-invasive thermal ablation device fully integrated with an MR imaging system being used for the ablation of tumor tissue

The InSightec ExAblate 2000 MRgHIFU system is a non-invasive device that is fully integrated with an MR imaging system and used for the ablation of soft tissue. The treatment process begins with the physician acquiring a set of MR images, identifying one or more target volume(s) of fibroid tissue to be ablated, and drawing the treatment contours. The therapy planning software computes the type and number of sonications required to treat the defined volume while minimizing total treatment time. MR images taken during the sonication provide a diagnostic quality image of the target tissue and a quantitative, real-time temperature map overlay to confirm the therapeutic effect of the treatment. The transducer is then automatically moved to the succeeding treatment point and the process is repeated until the entire volume has been treated. Approximately 100 individual sonications can be delivered over a 3-hour period to complete a treatment.

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

All participants were evaluated for adverse events.

Overall Safety - Incidence of Any Device-related Adverse Events

CTCAE Grade 1

CTCAE Grade 2

CTCAE Grade 3

CTCAE Grade 4

CTCAE Grade 5

Adverse Event Severity

The InSightec ExAblate 2000 MRgHIFU system is a non-invasive thermal ablation device fully integrated with an MR imaging system being used for the ablation of tumor tissue.

Due to the complexity of 3-dimensional mapping of tumors in soft tissues, the precision necessary to capture baseline tumor volume exceeded the capability of the equipment. Baseline data per protocol for the outcome calculation was only obtained from a single participant, resulting in an inability to conduct a robust per protocol analysis.

Percent Successful Tumor Ablation

Overall Study

Digestive System Diseases

Skin and Connective Tissue Diseases

Rare Diseases

Gastrointestinal Stromal Tumors

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Mona-Elisabeth Revheim, MD

Therese Seierstad, PhD

Øyvind S Bruland, Prof., MD

Knut Håkon Hole, MD

Lars Julsrud, MD

The purpose of this study is to compare sensitivity, specificity and accuracy of PET, DW MRI and CT separately and combined for the evaluation of treatment response and progression-free survival in patients with GIST.

Treatment Response Evaluation in Gastrointestinal Stromal Tumor (GIST) Patients

Treatment Response Evaluation in Patients With Gastrointestinal Stromal Tumor Using PET/CT and DW MRI

Oslo University Hospital

Nuclear Medicine Phycisian

Symptoms and General Pathology

Immune System Diseases

Blood and Lymph Conditions

Behaviors and Mental Disorders

Nervous System Diseases

Syndrome

Mastocytosis

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Preleukemia

Leukemia, Myelomonocytic, Chronic

Leukemia, Myelomonocytic, Juvenile

Myelodysplastic Syndromes

Hypersensitivity

Skin Diseases

Hematologic Neoplasms

Myeloproliferative Disorders

Aggression

Urticaria

Hematologic Diseases

Mastocytosis, Systemic

Leukemia, Mast-Cell

Urticaria Pigmentosa

Immune Complex Diseases

Dementia

Aberrant Motor Behavior in Dementia

Behavioral Symptoms

Mast Cell Activation Disorders

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Chronic Myelomonocytic Leukemia

Juvenile Myelomonocytic Leukemia

Chronic Graft Versus Host Disease

Acute Graft Versus Host Disease

Chronic Myeloproliferative Disorders

Systemic Mastocytosis

Antigen-Antibody Complex

Bezuclastinib is administered as tablets to be taken orally, continuously in 28-day cycles.

bezuclastinib

Hina Jolin, PharmD

Rachael Easton, MD, Ph.D.

This is an open-label, two-part Phase 2 study investigating CGT9486 for the treatment of patients with Advanced Systemic Mastocytosis (AdvSM), including patients with Aggressive SM (ASM), SM with Associated Hematologic Neoplasm (SM-AHN), and Mast Cell Leukemia (MCL).

There are two parts to this study, including Part I, Dose Optimization, and Part II Expansion. Part II is separated into two stages.

(Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis

A Phase 2 Open-Label, Multicenter Clinical Study of the Safety, Efficacy, Pharmacokinetic, and Pharmacodynamic Profiles of CGT9486 as a Single Agent in Patients With Advanced Systemic Mastocytosis

Incidence of AEs according to CTCAE version 5.0 or higher

Percentage change in plasma concentrations of bezuclastinib

Percentage change in mast cell infiltration in the bone marrow and percentage change in eosinophilia and monocytosis in the blood

0 -10 points (higher values represent worse symptom outcomes)

0 - 7 points (higher values represent better symptom outcomes)

0 - 100 (higher values represent better symptom outcomes)

0 - 252 (higher values represent worse symptom outcomes)

Cogent Biosciences, Inc.

Musculoskeletal Diseases

Sarcoma

Sarcoma, Ewing

Neuroectodermal Tumors, Primitive, Peripheral

Bone Neoplasms

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Osteosarcoma

Neoplasms, Bone Tissue

Bone Diseases

Soft Tissue Sarcoma

Ewing Sarcoma

Neuroepithelioma

The aim of this study is to identify demographic \& disease characteristics in pediatric oncology patients diagnosed with Ewing Sarcoma Family of Tumors (ESFT) \& treatment outcomes in these patients.

Ewing sarcoma (ES) and peripheral primitive neuroectodermal tumor (PNET), Both entities that currently comprise the same spectrum of neoplastic diseases known as the Ewing sarcoma family of tumors (EFT), were originally described as distinct clinicopathologic entities. Primitive neuroectodermal tumors (PNETs) first described in 1918 by Stout as a malignant tumor arising from major nerve. Later, in 1921, ES was described as an undifferentiated tumor involving the diaphysis of long bones. It was also reported to arise in soft tissue (extraosseous ES). EFT is aggressive malignant small round cell tumors of bone and soft-tissue that predominantly affecting children and young adults.

Ewing Sarcoma Family of Tumors (ESFT): A 15-year Experience From a Tertiary Care Cancer Center in Upper Egypt

Participants will be retrospectively followed forward in time from the date of initiation of treatment till death from any cause, an expected average of 5 years

Participants will be retrospectively followed forward in time from the date of initiation of treatment till occurrence of an event from any cause (tumor progression, relapse) or death, an expected average of 5 years

Assiut University

Lecturer of Pediatric Oncology

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Feasibility of ExAblate MRI Guided High Intensity Focused Ultrasound Tx of Soft Tissue Tumors	NCT01965002	Soft Tissue Neo...	MRgHIFU Aspirin Enoxaparin	10 Years -	Stanford University
Treatment Response Evaluation in Gastrointestinal Stromal Tumor (GIST) Patients	NCT01276483	Soft Tissue Neo... Gastrointestina...		-	Oslo University Hospital
(Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis	NCT04996875	Advanced System... SM With an Asso... Mast Cell Leuke... Aggressive Syst...	bezuclastinib	18 Years -	Cogent Biosciences, Inc.
Ewing Sarcoma Family of Tumors (ESFT): A 15-year Experience From a Tertiary Care Cancer Center in Upper Egypt	NCT04300179	Soft Tissue Neo... Bone Neoplasms Neoplasms		- 19 Years	Assiut University

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