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Trial record 1 of 1 for:    focused ultrasound | Head and Neck Cancer | Canada
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MRG FU With Radiotherapy for Palliation of H&N Cancer

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ClinicalTrials.gov Identifier: NCT03218475
Recruitment Status : Suspended (On hold pending amendment approval)
First Posted : July 14, 2017
Last Update Posted : April 4, 2019
Sponsor:
Collaborator:
Focused Ultrasound Foundation
Information provided by (Responsible Party):
Dr. Irene Karam, Sunnybrook Health Sciences Centre

Tracking Information
First Submitted Date  ICMJE February 16, 2017
First Posted Date  ICMJE July 14, 2017
Last Update Posted Date April 4, 2019
Actual Study Start Date  ICMJE July 28, 2016
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2018)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 12, 2017)
  • 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.
  • 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.
Change History Complete list of historical versions of study NCT03218475 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2018)
Treatment Effect [ Time Frame: 90 days ]
Assessment of changes caused by MR guided FU within the treated tumour region based on post treatment MRI
Original Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2017)
Treatment Effect [ Time Frame: 14 days ]
Assessment of changes caused by MR guided HIFU within the treated tumour region based on post treatment MRI
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MRG FU With Radiotherapy for Palliation of H&N Cancer
Official Title  ICMJE Magnetic Resonance-Guided Focused Ultrasound Combined With Radiotherapy for Palliation of Head and Neck Cancer - A Pilot Study
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Head and Neck Cancer
Intervention  ICMJE Other: MR Guided Focused Ultrasound
Two treatments of focused ultrasound under MRI guidance
Study Arms  ICMJE Experimental: MR Guided Focused Ultrasound
Intervention: Other: MR Guided Focused Ultrasound
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: July 12, 2017)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03218475
Other Study ID Numbers  ICMJE 229-2016
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Irene Karam, Sunnybrook Health Sciences Centre
Study Sponsor  ICMJE Sunnybrook Health Sciences Centre
Collaborators  ICMJE Focused Ultrasound Foundation
Investigators  ICMJE
Principal Investigator: Irene Karam, MD Sunnybrook Health Sciences Centre
PRS Account Sunnybrook Health Sciences Centre
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP