Trial Outcomes & Findings for Feasibility of ExAblate MRI Guided High Intensity Focused Ultrasound Tx of Soft Tissue Tumors (NCT NCT01965002)

NCT ID: NCT01965002

Last Updated: 2018-05-23

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

5 participants

Primary outcome timeframe

1 week

Results posted on

2018-05-23

Participant Flow

Participant milestones

Participant milestones
Measure	MRgHIFU 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.
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MRgHIFU n=5 Participants 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 <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 week

Population: All participants were evaluated for adverse events.

Outcome measures

Outcome measures
Measure	MRgHIFU n=5 Participants 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
Overall Safety - Incidence of Any Device-related Adverse Events	8 device-related adverse events

SECONDARY outcome

Timeframe: 6 months

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

Outcome measures

Outcome measures
Measure	MRgHIFU n=5 Participants 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
Adverse Event Severity CTCAE Grade 1	8 Treatment-related adverse events
Adverse Event Severity CTCAE Grade 2	0 Treatment-related adverse events
Adverse Event Severity CTCAE Grade 3	0 Treatment-related adverse events
Adverse Event Severity CTCAE Grade 4	0 Treatment-related adverse events
Adverse Event Severity CTCAE Grade 5	0 Treatment-related adverse events

SECONDARY outcome

Timeframe: Up to 1 week

Population: 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.

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.

Outcome measures

Outcome measures
Measure	MRgHIFU n=1 Participants 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
Percent Successful Tumor Ablation	40 percent ablated volume

Adverse Events

MRgHIFU

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	MRgHIFU n=5 participants at risk 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
General disorders Pain at tumor site	20.0% 1/5 • Number of events 1 • up to 10 months
Skin and subcutaneous tissue disorders Edema at right distal thigh	20.0% 1/5 • Number of events 1 • up to 10 months
Musculoskeletal and connective tissue disorders Mild backache from positioning	20.0% 1/5 • Number of events 1 • up to 10 months
Musculoskeletal and connective tissue disorders Diminished sensation along medial thigh	20.0% 1/5 • Number of events 1 • up to 10 months
Skin and subcutaneous tissue disorders Mild erythema	20.0% 1/5 • Number of events 1 • up to 10 months
Musculoskeletal and connective tissue disorders Slight numbness along distal aspect of the incision	20.0% 1/5 • Number of events 1 • up to 10 months
Musculoskeletal and connective tissue disorders Mild pain at tumor site	20.0% 1/5 • Number of events 1 • up to 10 months
Musculoskeletal and connective tissue disorders Reduced range of motion in right knee	20.0% 1/5 • Number of events 1 • up to 10 months

Additional Information

Pejman Ghanouni, MD, PhD

Stanford Univeristy Medical Center

Phone: 650-498-4485

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place