Trials / Completed
CompletedNCT02076906
MR-guided High Intensity Focused Ultrasound (HIFU) on Pediatric Solid Tumors
Safety and Feasibility Study of Using MR-guided High Intensity Focused Ultrasound (HIFU) for the Ablation of Relapsed or Refractory Pediatric Solid Tumors
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 7 (actual)
- Sponsor
- AeRang Kim · Academic / Other
- Sex
- All
- Age
- 30 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine if Magnetic Resonance guided High Intensity Focused Ultrasound ablative therapy is safe and feasible for children, adolescents, and young adults with refractory or relapsed solid tumors.
Detailed description
Magnetic Resonance (MR)-guided high intensity focused ultrasound (HIFU) is an innovative technique that allows for non-invasive thermal ablation of tissue. Advantages over conventional local tumor control such as surgery, radiation, or radiofrequency are that MR-HIFU is completely non-invasive, non-ionizing, and enables ablation of large tumor volumes with avoidance of adjacent tissue injury. This study will evaluate the safety and feasibility of MR-HIFU ablative therapy in children, adolescents, and young adults with refractory or relapsed solid tumors that are located in bone or soft tissue in close proximity to bone. Patients ≤ 30 years of age with refractory or relapsed solid tumors with measurable target lesions that are located in bone or soft tissue in close proximity to bone are eligible. Tolerability will be defined during the 14 days following MR-HIFU ablation. Patients will continue to be followed for tumor response and secondary outcomes for up to one year post ablation treatment.
Conditions
- Relapsed Pediatric Solid Tumors
- Refractory Pediatric Solid Tumors
- Rhabdomyosarcoma
- Ewing Sarcoma
- Osteosarcoma
- Neuroblastoma
- Wilms Tumor
- Hepatic Tumor
- Germ Cell Tumor
- Desmoid Tumor
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Magnetic Resonance High Intensity Focused Ultrasound | MR-High intensity focused ultrasound (HIFU) is an ultrasound based technology which allows for non-invasive thermal ablation of tumors under the guidance of MR thermography. |
Timeline
- Start date
- 2014-04-01
- Primary completion
- 2021-12-27
- Completion
- 2024-11-24
- First posted
- 2014-03-04
- Last updated
- 2025-01-01
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02076906. Inclusion in this directory is not an endorsement.