Novel MRI-Guided Ultrasound Stimulated Microbubble Radiation Treatment for Patients With Head and Neck Cancer
Overview
- Phase
- Phase 1
- Intervention
- Sonalleve Focused Ultrasound Device
- Conditions
- Head and Neck Cancer
- Sponsor
- Sunnybrook Health Sciences Centre
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Incidence of toxicity and adverse events using MRg-FUS MB treatment in patients with head and neck cancer
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
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.
Investigators
Dr. Gregory Czarnota
Senior Scientist, MD
Sunnybrook Health Sciences Centre
Eligibility Criteria
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.
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.
Arms & Interventions
MRg-FUS MB Treatment
Patients with head and neck cancer will receive MRI-guided ultrasound-stimulated microbubble-treatment combined with radiotherapy on a LINAC.
Intervention: Sonalleve Focused Ultrasound Device
MRg-FUS MB Treatment
Patients with head and neck cancer will receive MRI-guided ultrasound-stimulated microbubble-treatment combined with radiotherapy on a LINAC.
Intervention: DEFINITY
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Radiological response(90 days)