Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia

October 4, 2017 updated by: Washington University School of Medicine

A Feasibility Study of Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia in Human Subjects

This study will help to elucidate the treatment sites in the extremities and pelvis for which MR-guided HIFU heating is feasible, which has the potential to be beneficial for patients with conditions at those sites (soft tissue sarcoma, cervical cancer, etc.). The investigators anticipate that successful completion of this study will lead to clinical trials in those feasible sites of interest to determine the safety and efficacy of administering therapeutic levels of heat for hyperthermia or other applications.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • At least 18 years of age
  • Willing and able to provide informed consent
  • Patients only: must have a tumor in extremity muscle tissue or in the pelvis.

Exclusion Criteria:

  • Contraindications for MRI (e.g., unsafe MRI implanted devices, shrapnel, history of metal fragments in eyes, neurostimulators, excessive size and weight, claustrophobia)
  • Pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MR-HIFU
  • Philips 1.5T MRI scanner equipped with a Sonalleve V2 HIFU system will be used
  • Will be scanned in the MRI in 1 or more positions to the extremities and/or pelvis while aligned to the HIFU system. The HIFU device will then be used to apply sub-clinical levels (≤ 41°C) of heat to one or more small volumes. Regions will be heated to the desired temperature for variable short durations of time not exceeding 30 minutes.
  • After the session is complete, the patient will be removed from the MR-HIFU system and, following a 15-30-minute period of monitoring for any adverse events, allowed to leave.
  • Before the scan, after the scan and 5-10 days following the scan, participants will be asked to rate any pain, discomfort, in the area to be heated, as well as any anxiety or claustrophobia on a scale of 1-10 with 1 being minimal/none and 10 being extreme. The skin area to be treated will also be reviewed for any redness/discoloration.
Device: Magnetic Resonance-guided High-Intensity Focused Ultrasound
-Heating will not be performed in two areas of the body near each other (for example, not heating in two different places of the same thigh) to minimize the risk of overheating any one part of the subject's body. Heating a second target site is not mandatory, even if time allows, and the participant may refuse.
Other Names:
  • MR-HIFU

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility of the MR-HIFU device as measured by whether an area can be heated to the designated temperature and held at that temperature for an appropriate time frame
Time Frame: 1 day (2 hour timeframe)
-Temperature in the participant will be monitored using MR thermometry with the MR scanner
1 day (2 hour timeframe)
Feasibility of the MR-HIFU device as measured by whether an area can be heated while simultaneously maintaining patient comfort
Time Frame: Up to 10 days
  • Patient comfort will be measured by the Comfort Score. Before the scan, participants will be asked to rate any pain, discomfort, in the area to be heated, as well as any anxiety or claustrophobia on a scale of 1-10 with 1 being minimal/none and 10 being extreme. The skin area to be treated will also be reviewed for any redness/discoloration. After the scan, the same questions will be asked again of the subject.
  • Participants will be contacted by phone 5-10 days following participation in the study. Participants will be asked to describe any negative effects in the area heated since participation in the study, including pain, discomfort, and/or cosmetic changes (such as skin redness). Participants will be asked to score pain/discomfort on a scale of 1-10, with 1 being minimal/none and 10 being extreme.
Up to 10 days
Feasibility of the MR-HIFU device as measured by whether coupling can be maintained with the body area in the same position while having contact with the transducer for an appropriate time frame.
Time Frame: 1 day (2 hour timeframe)
-Patients' skin will be cooled using the MR-HIFU system's direct skin cooling device to minimize over heating of the skin, unless one or more gel pads are required to achieve proper coupling to the HIFU system. In order to ensure good contact with the surface of the HIFU interface, participants may be shaved or have other hair-removal products applied to limited regions of their body.
1 day (2 hour timeframe)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Behavior of hyperthermia delivery as measured by the build-up of time until the different treatment cells can reach a desired uniform temperature
Time Frame: 1 day (2 hour time frame)
--Temperature in the participant will be monitored using MR thermometry with the MR scanner
1 day (2 hour time frame)
Behavior of hyperthermia delivery as measured by if the heating cell behavior is the same in healthy and tumor tissues
Time Frame: 1 day (2 hour time frame)
--Temperature in the participant will be monitored using MR thermometry with the MR scanner
1 day (2 hour time frame)
Behavior of hyperthermia delivery as measured by post-treatment heat diffusion behavior to anticipate any issues when heat is given at a clinically relevant level
Time Frame: Up to 10 days
-Participants will be contacted by phone 5-10 days following participation in the study. Participants will be asked to describe any negative effects in the area heated since participation in the study, including pain, discomfort, and/or cosmetic changes (such as skin redness).
Up to 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Washington University School of Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael Altman, Ph.D., Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 30, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 29, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 29, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 2, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 6, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201612155

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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