MRG HIFU With Radiation Therapy for Palliation of H&N Cancer

Official Title

Magnetic Resonance-Guided High Intensity Focused Ultrasound Combined With Radiation Therapy for Palliation of Head and Neck Cancer - A Pilot Study

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 high intensity focused ultrasound (HIFU).

Trial Description

Primary Outcome:

  • Safety and Toxicity Assessment of MRg-HIFU Treatment to the Head and Neck Region.
  • Feasibility of MRg-HIFU Treatments to the Head and Neck Region
Secondary Outcome:
  • Treatment Effect
This is a single institution, prospective pilot study to evaluate the safety and feasibility of MR guided high intensity focused ultrasound (HIFU) treatment for cancer of the neck in 10 patients. The procedure will consist of a planning MRI scan and a treatment session where real time MRI thermometry is used in conjunction with a focused beam to produce hyperthermia (55-90 degrees celsius for 20-30 seconds) within a pre-selected target lesion. All patients will be assessed by a physician investigator and clinical research assistant (CRA) on the day of treatment (day 0) and days 1, 7, 14, 30 and 90 post MR guided HIFU. In addition, at each visit including the treatment date, a Pain and Analgesics Form and an Anticipated Adverse Effects Screening Assessment will be completed by the CRA and physician with the patient. If specific adverse effects are identified, then the National Cancer Institute Common Toxicity Criteria (NCI CTCAE v4.03) will be used to assign a grade/score to the severity of the effect. All patients will undergo a follow-up MRI on day 14 and begin standard palliative radiation therapy/chemotherapy beginning no sooner than day 14 after the HIFU treatment.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society