oral cancer oral tumor
Conditions
Interventions
Ultrasound and microbubbles
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age > 18 years - Squamous cell carcinoma of the oral cavity - Preferably, locally advanced tumor - Has signed and dated written informed consent before performing any study proce-dure, including screening. - Tumor within reach of the US-probe - Tumor visible on US (B-mode)
Exclusion criteria
Exclusion criteria: - Contraindications to ultrasound contrast agents - Prior chemotherapy - Prior radiotherapy - Prior surgery/ablative therapy - Any other medical or social condition that, in the opinion of the Principal Investigator, might put the subject at risk of harm during the study or might adversely affect the in-terpretation of the study data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of our study is to determine the change in tumor perfusion induced by an USMB treatment and its safety. Change in tumor perfusion is assessed by contrast-enhanced ultrasound (CEUS) imaging Safety is assessed by: - Reporting adverse events according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. We will assess treatment-related adverse events by evaluating the treatment site for redness, numbness, swelling, and pain, scored with the 5-point Likert scale. - Reporting numeric rating scale (NRS) pain scores - Histopathology to determine vascular damage and tumor necrosis | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoint of our study is to elucidate the underlying mechanism(s) causing the perfusion change. This assessed by: - Performing additional histopathologic stains (e.g. hypoxia markers) on the excised tumor - Extensive characterization of tumor morphology/physiology with US imaging | — |
Countries
Netherlands
Contacts
Public ContactA.J. Kortenbout
Universitair Medisch Centrum Utrecht
Outcome results
None listed