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MRG FU With Radiotherapy for Palliation of H&N Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03218475
Recruitment Status : Recruiting
First Posted : July 14, 2017
Last Update Posted : September 7, 2018
Focused Ultrasound Foundation
Information provided by (Responsible Party):
Dr. Irene Karam, Sunnybrook Health Sciences Centre

Brief 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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Other: MR Guided Focused Ultrasound Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Magnetic Resonance-Guided Focused Ultrasound Combined With Radiotherapy for Palliation of Head and Neck Cancer - A Pilot Study
Actual Study Start Date : July 28, 2016
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: MR Guided Focused Ultrasound Other: MR Guided Focused Ultrasound
Two treatments of focused ultrasound under MRI guidance

Primary Outcome Measures :
  1. Safety and Toxicity Assessment of MRg-FU Treatment to the Head and Neck Region. [ Time Frame: 90 days ]
    The number, type and severity of adverse effects as assessed using NCI CTCAE v4.03.

  2. Feasibility of MRg-FU Treatments to the Head and Neck Region [ Time Frame: 90 days ]
    The number of patients that meet the eligibility criteria and are able to complete the study treatment protocol.

Secondary Outcome Measures :
  1. Treatment Effect [ Time Frame: 90 days ]
    Assessment of changes caused by MR guided FU within the treated tumour region based on post treatment MRI

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age ≥18 years
  • Able to give informed consent
  • Weight <140kg
  • Biopsy-proven diagnosis of squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma from any primary site with demonstrated metastatic nodal disease in the head and neck region
  • Assessed by the treating surgeon, and radiation oncologist, and following a multidisciplinary discussion, determined to have unresectable and/or inoperable disease in the head and neck region in the presence or absence of distant metastases.
  • Radiologic evidence of neck lymphadenopathy with at least one target lesion measuring > 1cm in largest dimension. (Recurrent or initial presentation)
  • Assessed by the treating radiation/medical oncologists to undergo palliative radiotherapy and/or chemotherapy
  • Target lesion visible by non-contrast MRI
  • Target lesion accessible for MRg-FU procedure
  • Able to communicate sensation during MRg-FU treatment

Exclusion Criteria:

  • Pregnant / Nursing woman
  • Unable to have contrast-enhanced MRI scan - standard institutional criteria
  • Head and neck surgery(excluding biopsy) ≤ 6 weeks prior to study enrolment
  • Chemotherapy ≤ 6 weeks prior to enrolment
  • Previous radiotherapy to target region ≤ 6 weeks prior to enrolment
  • Target lesion involves the skin surface causing ulceration, bleeding or discharge
  • Target lesion in contact with hollow viscera
  • Target lesion located in skull, spine, or mandible
  • Fibrotic scar along proposed HIFU beam path
  • Orthopaedic implant along proposed HIFU beam path or at site of target lesion.
  • Severe cardiovascular, neurological, renal or hematological chronic disease
  • ECOG (Eastern Cooperative Oncology Group) Performance Status ≥ 3.
  • Active infection
  • Unable to tolerate required stationary position during treatment
  • Allergy to MRI contrast agent or sedation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03218475

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Contact: Irene Karam, MD 4164806100 ext 4974
Contact: Merrylee McGuffin, MSc 4164806100 ext 85454

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Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4L 1S4
Contact: Irene Karam, MD    416-480-6100 ext 4974   
Contact: Merrylee McGuffin, MSc    4164806100 ext 85454   
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Focused Ultrasound Foundation
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Principal Investigator: Irene Karam, MD Sunnybrook Health Sciences Centre

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Responsible Party: Dr. Irene Karam, Radiation Oncologist, Sunnybrook Health Sciences Centre Identifier: NCT03218475     History of Changes
Other Study ID Numbers: 229-2016
First Posted: July 14, 2017    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site