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Trial record 30 of 348 for:    high intensity | Canada

MRG HIFU With Radiotherapy for Palliation of H&N Cancer

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ClinicalTrials.gov Identifier: NCT03218475
Recruitment Status : Recruiting
First Posted : July 14, 2017
Last Update Posted : July 14, 2017
Sponsor:
Collaborator:
Focused Ultrasound Foundation
Information provided by (Responsible Party):
Dr. Justin Lee, 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 high intensity focused ultrasound (HIFU).

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

Detailed Description:
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 radiotherapy/chemotherapy beginning no sooner than day 14 after the HIFU treatment.

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 High Intensity 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 HIFU Other: MR Guided HIFU
Single treatment of high intensity focused ultrasound under MRI guidance




Primary Outcome Measures :
  1. Safety and Toxicity Assessment of MRg-HIFU 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-HIFU 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: 14 days ]
    Assessment of changes caused by MR guided HIFU within the treated tumour region based on post treatment MRI



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

Inclusion Criteria:

  • Age ≥18 years
  • Able to give informed consent
  • Weight <140kg
  • Biopsy-proven diagnosis of squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma involving the head and neck region (skin primary, nasopharynx primary, unknown primary are included)
  • Radiologic evidence of metastatic disease involving the lungs, liver or bone
  • Radiologic evidence of neck lymphadenopathy with at least one target lesion measuring > 3cm 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-HIFU procedure
  • Able to communicate sensation during MRg-HIFU 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 circumferentially encompasses major blood vessel (carotid or jugular)
  • 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 ClinicalTrials.gov identifier (NCT number): NCT03218475


Contacts
Contact: Justin Lee, MD 4164806100 ext 7150 Justin.Lee@sunnybrook.ca
Contact: Merrylee McGuffin, MSc 4164806100 ext 85454 Merrylee.Mcguffin@sunnybrook.ca

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4L 1S4
Contact: Justin Lee, MD    416-480-6100 ext 7150    Justin.Lee@sunnybrook.ca   
Contact: Merrylee McGuffin, MSc    4164806100 ext 85454    Merrylee.Mcguffin@sunnybrook.ca   
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Focused Ultrasound Foundation
Investigators
Principal Investigator: Justin Lee, MD Sunnybrook Health Sciences Centre

Responsible Party: Dr. Justin Lee, Radiation Oncologist, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT03218475     History of Changes
Other Study ID Numbers: 229-2016
First Posted: July 14, 2017    Key Record Dates
Last Update Posted: July 14, 2017
Last Verified: July 2017

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

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