Recruiting
Phase 1

MRI-Guided Ultrasound

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT04431648

Conditions

Head and Neck Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

DEFINITY

Sonalleve Focused Ultrasound Device

Study Details

Brief summary:

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.

Conditions

Head and Neck Cancer

Study ID

NCT04431648

Start date

May 1, 2020

Status verified date

Dec, 2023

Completion date

May 1, 2024

Anticipated

Primary completion date

May 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

DEFINITY

MRI-guided ultrasound-stimulated microbubble-treatment

Sonalleve Focused Ultrasound Device

Sonalleve Focused Ultrasound Device

Primary outcome measure

  • Incidence of toxicity and adverse events using MRg-FUS MB treatment in patients with head and neck cancer [ Time Frame: 90 days ]

Central Contacts and Locations

Central contacts

Shopnil Prasla

416-480-6100shopnil.prasla@sri.utoronto.ca

Maria L Anzola Pena

416-480-6100marialourdes.anzolapena@sri.utoronto.ca

Locations

Gregory J Czarnota

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Gregory J Czarnota, PhD, MD

(416)480-6128gregory.czarnota@sunnybrook.ca

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Dec 13, 2023

Last verified

Dec, 2023

Keywords

  • Head and Neck Cancer
  • Focused Ultrasound
  • Microbubble

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2023-12-13.