search
Back to results

MRG FU With Radiotherapy for Palliation of H&N Cancer

Primary Purpose

Head and Neck Cancer

Status
Suspended
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
MR Guided Focused Ultrasound
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Head and Neck Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sunnybrook Health Sciences Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MR Guided Focused Ultrasound

Arm Description

Outcomes

Primary Outcome Measures

Safety and Toxicity Assessment of MRg-FU Treatment to the Head and Neck Region.
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
The number of patients that meet the eligibility criteria and are able to complete the study treatment protocol.

Secondary Outcome Measures

Treatment Effect
Assessment of changes caused by MR guided FU within the treated tumour region based on post treatment MRI

Full Information

First Posted
February 16, 2017
Last Updated
May 19, 2023
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Focused Ultrasound Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT03218475
Brief Title
MRG FU With Radiotherapy for Palliation of H&N Cancer
Official Title
Magnetic Resonance-Guided Focused Ultrasound Combined With Radiotherapy for Palliation of Head and Neck Cancer - A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Suspended
Why Stopped
On hold pending amendment approval
Study Start Date
July 28, 2016 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Focused Ultrasound Foundation

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MR Guided Focused Ultrasound
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
MR Guided Focused Ultrasound
Intervention Description
Two treatments of focused ultrasound under MRI guidance
Primary Outcome Measure Information:
Title
Safety and Toxicity Assessment of MRg-FU Treatment to the Head and Neck Region.
Description
The number, type and severity of adverse effects as assessed using NCI CTCAE v4.03.
Time Frame
90 days
Title
Feasibility of MRg-FU Treatments to the Head and Neck Region
Description
The number of patients that meet the eligibility criteria and are able to complete the study treatment protocol.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Treatment Effect
Description
Assessment of changes caused by MR guided FU within the treated tumour region based on post treatment MRI
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irene Karam, MD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4L 1S4
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

MRG FU With Radiotherapy for Palliation of H&N Cancer

We'll reach out to this number within 24 hrs