Soft Tissue NeoplasmsNCT01965002
Feasibility of ExAblate MRI Guided High Intensity Focused Ultrasound Tx of Soft Tissue Tumors
A study testing MRgHIFU, Aspirin and Enoxaparin in people with Soft Tissue Neoplasms, run by Pejman Ghanouni at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Soft Tissue Neoplasms
- What is being tested?
- MRgHIFU, Aspirin and Enoxaparin
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to 24 Mar 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ≥ 10 years of age.
- Benign or malignant soft tissue tumors of the extremities, flanks, pelvis, or shoulders requiring surgical intervention.
- Tumor must not have been treated previously with radiation.
- Targeted tumor(s) are accessible to the ExAblate device
- Targeted volume within the tumor is located deeper than 1 cm from the skin
- Targeted tumor is clearly visible by non-contrast magnetic resonance imaging (MRI)
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- Karnofsky Performance Status > 60
- Normal platelet count and coagulation profile
- Glomerular filtration rate > 60 mL/min
- Able to safely undergo MRI exam and receive mild sedation for the treatment.
- Able to tolerate being in the MRI scanner for the duration of the study.
- Able and willing to give consent (or consent + assent where applicable), and able to attend all study visits.
Who cannot join
- Previous radiation treatment to the tumor.
- Currently receiving dialysis.
- Acute medical condition (eg, pneumonia, sepsis) expected to hinder completion of the study
- Unstable cardiac status including:
- Unstable angina pectoris on medication
- Patients with documented myocardial infarction within six months of protocol entry
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- Congestive heart failure requiring medication (other than diuretic)
- Patients on anti-arrhythmic drugs
- Severe hypertension (diastolic BP > 100 on medication)
- Contraindication for MR imaging such as implanted metallic devices that are not MRI-safe, size limitations, etc
- Severe hematologic, neurologic, or other uncontrolled disease
- Known intolerance or allergy to medications used for sedation (midazolam), analgesia (fentanyl), and local and regional anesthesia (lidocaine, bupivacaine, and ropivacaine)
- Known intolerance or allergy to MR contrast agent (gadolinium chelates) including advanced kidney disease
- Pregnant and nursing
- Karnofsky Performance Score < 60
- Severe cerebrovascular disease [cardiovascular accident (CVA) within 6 months]
- Not able or not willing to tolerate the required prolonged stationary position during treatment (up to 5 hrs of total table time)
- Target volume in tumor is less than 1 cm from neurovascular bundles, major blood vessels, bowel, or bladder.
- Targeted tumors:
- NOT visible by non-contrast MRI, OR
- NOT accessible to ExAblate device
- Not a candidate for either regional anesthesia or mild sedation
- Not be participating in another trial testing other investigational agents or devices
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Soft Tissue Neoplasms
- Being tested
- MRgHIFU, Aspirin, Enoxaparin
- Medical subject headings
- Soft Tissue Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRgHIFUDevice
Also called ExAblate Magnetic Resonance Imaging Guided High Intensity Focused Ultrasound
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
AspirinDrug
Also called Ecotrin
325 mg PO for deep venous thrombosis (DVT) prophylaxis initiated 2 hours prior to magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) treatment
EnoxaparinDrug
Also called Lovenox
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
| Study group | Role | What they receive |
|---|---|---|
| MRgHIFU | Experimental | 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. Receives: Device: MRgHIFU; Drug: Aspirin; Drug: Enoxaparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Safety - Incidence of Any Device-related Adverse Events
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.
Measured: 1 week
Secondary outcomes (2)
Adverse Event Severity
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:
- mild
- moderate
- severe
- life-threatening
- fatal
Measured: 6 months
Percent Successful Tumor Ablation
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.
Measured: Up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2013 (estimated)
- Study startMay 2014
- Primary completion24 Mar 2015
- Study completion24 Mar 2015
Why it stopped: Accrual factor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Soft Tissue NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pejman Ghanouni
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pejman Ghanouni, Stanford University
- Investigators
- Raffi Avedian, MD, Principal investigator, Stanford UniversityPejman Ghanouni, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01965002
- Sponsor's protocol ID
- IRB-26667
- Other IDs
- VAR0095
- Status last verified
- Apr 2018
- First submitted
- 15 Oct 2013
- Last updated
- 23 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01965002
- Acronym / sponsor ID
- IRB-26667
- Conditions
- Soft Tissue Neoplasms
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Accrual factor
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Pejman GhanouniUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- 24 Mar 2015 (actual)
- Study completion
- 24 Mar 2015 (actual)
- First posted
- 17 Oct 2013 (estimated)
- Results
- Posted 23 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRgHIFU | Experimental | Device: MRgHIFU, Drug: Aspirin, Drug: EnoxaparinThe 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. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- ≥ 10 years of age.
- Benign or malignant soft tissue tumors of the extremities, flanks, pelvis, or shoulders requiring surgical intervention.
- Tumor must not have been treated previously with radiation.
- Targeted tumor(s) are accessible to the ExAblate device
- Targeted volume within the tumor is located deeper than 1 cm from the skin
Key exclusion criteria (23 listed)
- Previous radiation treatment to the tumor.
- Currently receiving dialysis.
- Acute medical condition (eg, pneumonia, sepsis) expected to hinder completion of the study
- Unstable cardiac status including:
- Severe hypertension (diastolic BP > 100 on medication)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRgHIFUAlso: ExAblate Magnetic Resonance Imaging Guided High Intensity Focused UltrasoundThe 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 | Device | MRgHIFU |
| AspirinAlso: Ecotrin325 mg PO for deep venous thrombosis (DVT) prophylaxis initiated 2 hours prior to magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) treatment | Drug | MRgHIFU |
| EnoxaparinAlso: Lovenox40 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 | Drug | MRgHIFU |
Primary outcome
Overall Safety - Incidence of Any Device-related Adverse Events
Time frame: 1 week
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.
2 secondary outcomes
Adverse Event Severity
Time frame: 6 months
Percent Successful Tumor Ablation
Time frame: Up to 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raffi Avedian, MD principal investigator
Stanford University
Pejman Ghanouni, MD, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRgHIFU, Aspirin and Enoxaparin in people with Soft Tissue Neoplasms, run by Pejman Ghanouni at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Safety - Incidence of Any Device-related Adverse Events (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2018.