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

NCT ID: NCT03007771

Last Updated: 2017-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-30

Study Completion Date

2018-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Participants Pelvic Neoplasms Soft-tissue Sarcoma Bladder Cancer Cervical Cancer Rectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Magnetic Resonance-guided High-Intensity Focused Ultrasound

Intervention Type DEVICE

-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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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MR-HIFU

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Altman, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Countries

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United States

Related Links

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http://www.siteman.wustl.edu

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Other Identifiers

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201612155

Identifier Type: -

Identifier Source: org_study_id