NCT03218475

MRG FU With Radiotherapy for Palliation of H&N Cancer

Magnetic Resonance-Guided Focused Ultrasound Combined With Radiotherapy for Palliation of Head and Neck Cancer - A Pilot Study

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Head and neck cancer is the sixth most common form of malignancy world-wide. Surgery, chemotherapy and radiation are associated with a high burden of side effects; tumour recurrence within the neck continues to be a major cause of treatment failure. To our knowledge, this research is the first clinical study in human subjects to utilize magnetic resonance guided focused ultrasound to treat cancer of the neck. The goal is to evaluate the safety and technical feasibility of this therapy in order to guide future clinical applications such as ablation, radiosensitization or drug delivery that could ultimately improve clinical outcomes. A total of 10 patients will be treated with MR guided focused ultrasound.

Detailed description

This is a single institution, prospective pilot study to evaluate the safety and feasibility of MR guided focused ultrasound treatment for cancer of the neck in 10 patients. The procedure will consist of a planning MRI scan and two treatment sessions where real time MRI thermometry is used in conjunction with a focused beam to heat the tissue to 40-42oC in the target field over a period of 20-30 seconds per treatment. All patients on the study will undergo palliative radiotherapy and/or chemotherapy. MRg-FU treatments will be delivered on fraction #1 and fraction #10 (50 Gy/20 regimen) or on fraction #1 and fraction #3 (35-45 Gy/5 SBRT regimen). Palliative radiotherapy treatment will be administered to the treatment target lesion and in addition may encompass other tumour regions of the head and neck. The prescribed dose for patients who have not received previous radiotherapy will be between 50Gy over 4 weeks using IMRT or VMAT -based planning or 35-45 Gy in 5 fractions using SBRT technique; in previously irradiated patients, the dose will be determined at the discretion of the treating radiation oncologist. The patient will be assessed by a physician investigator and clinical research assistant (CRA) on the MRg-FU treatment dates, then 1 day, 1 week, 2 weeks, 1 month and 3 months afterward.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
OTHER	MR Guided Focused Ultrasound	Two treatments of focused ultrasound under MRI guidance

Timeline

• Start date: 2016-07-28
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2017-07-14
• Last updated: 2023-05-23

Locations

1 site across 1 country: Canada