Novel MRI-Guided Ultrasound Stimulated Microbubble Radiation Treatment for Patients With Head and Neck Cancer

NCT04431648 | Unknown Phase 1 DMC

• 1 other identifier: 076-2019
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Head and Neck Cancer; Focused Ultrasound; Microbubble

Outcome Measures

Primary Outcomes (1)

• Incidence of toxicity and adverse events using MRg-FUS MB treatment in patients with head and neck cancer

  Incidence of toxicity and adverse events

  90 days

Secondary Outcomes (1)

• Radiological response

  90 days

Study Arms (1)

MRg-FUS MB Treatment

EXPERIMENTAL

Patients with head and neck cancer will receive MRI-guided ultrasound-stimulated microbubble-treatment combined with radiotherapy on a LINAC.

Drug: DEFINITY; Device: Sonalleve Focused Ultrasound Device

Interventions

DEFINITY DRUG

MRI-guided ultrasound-stimulated microbubble-treatment

MRg-FUS MB Treatment

Sonalleve Focused Ultrasound Device DEVICE

Sonalleve Focused Ultrasound Device

MRg-FUS MB Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Gregory J Czarnota

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

perflutren

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Gregory J Czarnota, PhD, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shopnil Prasla

CONTACT

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

Maria L Anzola Pena

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist, MD

Model Details: Prospective, Single-Centre, Single-Arm, Non-Randomized, Phase-I MRI-Guided Ultrasound Stimulated Microbubbles Radiation Treatment for Patients with Head and Neck Cancers

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: June 16, 2020
• Study Start: May 1, 2020
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: December 13, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)