- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04431648
Novel MRI-Guided Ultrasound Stimulated Microbubble Radiation Treatment for Patients With Head and Neck Cancer (USmBRT-H)
December 7, 2023 updated by: Dr. Gregory Czarnota, Sunnybrook Health Sciences Centre
The objective of this study is to demonstrate the feasibility of novel MRI-guided ultrasound stimulated microbubble treatment to enhance radiation effects in humans receiving external beam radiotherapy delivered using a LINAC (linear accelerator) radiation therapy device.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
This study is to demonstrate the feasibility of novel MRI-guided ultrasound stimulated microbubble treatment to enhance radiation effects in humans receiving external beam radiotherapy delivered using a LINAC (linear accelerator) radiation therapy device.
The investigators have previously demonstrated that ultrasound and microbubble mediated endothelial cell perturbation can significantly enhance the effectiveness of radiation.
It enhances tumour response to radiation significantly by synergistically destroying tumour blood vessels.
The technique is targeted spatially and achieves tumour specificity by confining the low-power ultrasonic fields that stimulate microbubbles to the tumour location only.
By perturbing the tumour vasculature and activating specific genetic pathways, the technique sensitizes the targeted tissues to the subsequent therapeutic application of radiation, resulting in significantly enhanced cell killing.
The primary aim of this research is to evaluate the safety profile of MRI-guided ultrasound stimulated microbubble treatment and radiation in patients with head and neck cancer.
The secondary aim is to evaluate tumor (primary and/or nodal) response to MRg-FU + MB and radiation, as measured radiologically within the treated therapeutic regions.
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Shopnil Prasla
- Phone Number: 89533 416-480-6100
- Email: shopnil.prasla@sri.utoronto.ca
Study Contact Backup
- Name: Maria L Anzola Pena
- Phone Number: 89533 416-480-6100
- Email: marialourdes.anzolapena@sri.utoronto.ca
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M4N 3M5
- Recruiting
- Gregory J Czarnota
-
Contact:
- Gregory J Czarnota, PhD, MD
- Phone Number: (416)480-6128
- Email: gregory.czarnota@sunnybrook.ca
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age ≥18 years
- All biopsy-confirmed squamous cell carcinoma (SCC) of the H&N including the following subregions: Larynx, Oropharynx, Hypopharynx, Oral Cavity, Salivary Glands, and Paranasal Sinuses
- Stage I-IV H&N cancers (i.e. cT1-T4, cN0-N3, cM0), per AJCC guidelines (8th Edition).
- 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.
- Patients referred for palliative radiotherapy or standard radiotherapy, including the following dose regimens: 70 Gy/35 fractions, 50 Gy/20 fractions, or 35-40 Gy/5 fractions (SBRT, hypofractionation).
- Patients treated with concurrent pre-operative chemoradiation, including: Cisplatin (40 mg/m2 q.w.k or Carboplatin 70 mg/m2 / day IV on days 1-4, 22-25 and at days 43-46 of radiation) or referred for palliative radiotherapy.
- Able to understand and give informed consent.
- Weight <140kg.
- Radiologic evidence of neck lymphadenopathy with at least one target lesion measuring > 1cm in largest dimension (Recurrent or initial presentation)
- Target lesion visible by non-contrast MRI.
- Target lesion accessible for MRg-FU procedure.
- Able to communicate sensation during MRg-FU treatment.
- Creatinine within normal institutional limits or creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional upper limit of normal
Exclusion Criteria:
- Pregnant or lactating women may not participate due to the embryotoxic effects of protocol treatment. Women/ men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
- Unable to have contrast-enhanced MRI scan - standard of care criteria
- Head and neck surgery (excluding biopsy) ≤ 6 weeks prior to study enrolment
- Chemotherapy or other systemic anti-cancer agents ≤ 1 week prior to enrolment unless cisplatin-based chemotherapy
- Previous radiotherapy ≤ 6 weeks prior to enrollment
- Target lesion involves the skin surface causing ulceration, bleeding or discharge
- Target lesion in contact with hollow viscera
- Target lesion located in the skull, spine, or mandible
- The fibrotic scar along the proposed FU beam path
- Orthopedic implant along proposed FU beam path or at a site of the target lesion.
- Severe cardiovascular, neurological, renal or hematological chronic disease
- ECOG (Eastern Cooperative Oncology Group) Performance Status ≥ 3. Unable to tolerate required stationary position during treatment
- Cardiac disease or unstable hemodynamics including myocardial infarction within six months, unstable angina, congestive heart failure, ejection fraction < 50%, cardiac shunts, cardiac arrythmia and cardiac pacemaker.
- Contraindication to perflutren including subjects with a family or personal history of QT prolongation or taking concomitant medications known to cause QTc prolongation like cisapride, erythromycin, tricyclic antidepressants, Class IA and III antiarrhythmic agents and some antipsychotics like haloperidol, droperidol, quetiapine, thioridazine, ziprasidone. QT prolongation observed on screening ECG (QTc > 450ms for men or >470ms for women)
- Severe hypertension (diastolic BP > 100 mmHg)
- History of bleeding disorder, coagulopathy
- Severely impaired renal function with estimated glomerular filtration rate < 30ml/min/1.73m2 and/or on dialysis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MRg-FUS MB Treatment
Patients with head and neck cancer will receive MRI-guided ultrasound-stimulated microbubble-treatment combined with radiotherapy on a LINAC.
|
Sonalleve Focused Ultrasound Device
MRI-guided ultrasound-stimulated microbubble-treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of toxicity and adverse events using MRg-FUS MB treatment in patients with head and neck cancer
Time Frame: 90 days
|
Incidence of toxicity and adverse events
|
90 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Radiological response
Time Frame: 90 days
|
The secondary endpoint is radiological response in head and neck cancer following MRg-FU + MB + radiation, after a 3 month follow up.
|
90 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Gregory J Czarnota, PhD, MD, Sunnybrook Health Sciences Centre
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2020
Primary Completion (Estimated)
May 1, 2024
Study Completion (Estimated)
May 1, 2024
Study Registration Dates
First Submitted
June 11, 2020
First Submitted That Met QC Criteria
June 11, 2020
First Posted (Actual)
June 16, 2020
Study Record Updates
Last Update Posted (Estimated)
December 13, 2023
Last Update Submitted That Met QC Criteria
December 7, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 076-2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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