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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MR-HIFU | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Resonance-guided High-Intensity Focused Ultrasound | 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. |
| 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 | -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 |
| 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. | -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) |
| 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 | --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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Altman, Ph.D. | Washington University School of Medicine | Principal Investigator |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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--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 | -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 |
| ID | Term |
|---|---|
| D010386 | Pelvic Neoplasms |
| D012509 | Sarcoma |
| D001749 | Urinary Bladder Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D000091662 | Genital Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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