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

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Recruiting
participants needed

20
sponsor

Sunnybrook Health Sciences Centre

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Updated on 19 February 2024

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cancer

electrolytes

carboplatin

squamous cell carcinoma

external beam radiotherapy

chemoradiotherapy

carcinoma

lymphadenopathy

head and neck cancer

dental caries

neck cancer

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.

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.

Details

Condition	head and neck cancer, head and neck cancer
Age	18-100 years
Treatment	Definity Suspension for Injection
Clinical Study Identifier	NCT04431648
Sponsor	Sunnybrook Health Sciences Centre
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Age 18 years
	All biopsy-confirmed squamous cell carcinoma (SCC) of the H&N within past three months 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 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)
	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
	Patients with normal coagulation profile, CBC, liver profile (bilirubin/ ALT/ALP), electrolytes (sodium, potassium, chloride, CO2 total), BUN and creatinine
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)
	Patients concurrently taking anti-coagulant therapy like antiplatelets or vitamin K inhibitors or heparin derivatives
	History of bleeding disorder, coagulopathy
	Severely impaired renal function with estimated glomerular filtration rate < 30ml/min/1.73m2 and/or on dialysis

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