NCT03218475

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
10

participants targeted

Target at below P25 for not_applicable head-and-neck-cancer

Timeline
Completed

Started Jul 2016

Longer than P75 for not_applicable head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 28, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2017

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 14, 2017

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

May 23, 2023

Status Verified

May 1, 2023

Enrollment Period

7.3 years

First QC Date

February 16, 2017

Last Update Submit

May 19, 2023

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (2)

  • 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.

    90 days

  • 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.

    90 days

Secondary Outcomes (1)

  • Treatment Effect

    90 days

Study Arms (1)

MR Guided Focused Ultrasound

EXPERIMENTAL
Other: MR Guided Focused Ultrasound

Interventions

MR Guided Focused UltrasoundOTHER

Two treatments of focused ultrasound under MRI guidance

MR Guided Focused Ultrasound

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4L 1S4, Canada

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Irene Karam, MD

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Radiation Oncologist

Study Record Dates

First Submitted

February 16, 2017

First Posted

July 14, 2017

Study Start

July 28, 2016

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

May 23, 2023

Record last verified: 2023-05

Locations

CA(1)