Head and Neck CancerNCT03218475
MRG FU With Radiotherapy for Palliation of H&N Cancer
A study testing MR Guided Focused Ultrasound in people with Head and Neck Cancer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- MR Guided Focused Ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 28 Jul 2016to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Magnetic Resonance-Guided Focused Ultrasound Combined With Radiotherapy for Palliation of Head and Neck Cancer - A Pilot Study
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.
Read the 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.
- Conditions
- Head and Neck Cancer
- Being tested
- MR Guided Focused Ultrasound
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR Guided Focused UltrasoundOther
Two treatments of focused ultrasound under MRI guidance
| Study group | Role | What they receive |
|---|---|---|
| MR Guided Focused Ultrasound | Experimental | Not described Receives: Other: MR Guided Focused Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 90 days
Secondary outcomes (1)
Treatment Effect
Assessment of changes caused by MR guided FU within the treated tumour region based on post treatment MRI
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start28 Jul 2016
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: On hold pending amendment approval
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Focused Ultrasound Foundation
- Responsible party
- Principal investigator, Dr. Irene Karam, Sunnybrook Health Sciences Centre
- Investigators
- Irene Karam, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03218475
- Sponsor's protocol ID
- 229-2016
- Status last verified
- May 2023
- First submitted
- 16 Feb 2017
- Last updated
- 23 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance-Guided Focused Ultrasound Combined With Radiotherapy for Palliation of Head and Neck Cancer - A Pilot Study
- ClinicalTrials.gov ID
- NCT03218475
- Acronym / sponsor ID
- 229-2016
- Conditions
- Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: On hold pending amendment approval
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Focused Ultrasound Foundation
- Study start
- 28 Jul 2016 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 14 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MR Guided Focused Ultrasound | Experimental | Other: MR Guided Focused Ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MR Guided Focused UltrasoundTwo treatments of focused ultrasound under MRI guidance | Other | MR Guided Focused Ultrasound |
Primary outcome
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.
1 secondary outcome
Treatment Effect
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irene Karam, MD principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MR Guided Focused Ultrasound in people with Head and Neck Cancer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Toxicity Assessment of MRg-FU Treatment to the Head and Neck Region. (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2023.