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

  • STATUS
    Recruiting
  • participants needed
    20
  • sponsor
    Sunnybrook Health Sciences Centre
Updated on 19 February 2024
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 IdentifierNCT04431648
SponsorSunnybrook Health Sciences Centre
Last Modified on19 February 2024

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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