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NCT04431648: USmBRT-H
Novel MRI-Guided Ultrasound Stimulated Microbubble Radiation Treatment for Patients With Head and Neck Cancer
Phase 1 trial testing DEFINITY in Head and Neck Cancer in 20 participants. Status unknown.
1 May 2024
Quick facts
| Lead sponsor | Sunnybrook Health Sciences Centre |
|---|---|
| Phase | Phase 1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 1 May 2020 |
| Primary completion | 1 May 2024 |
| Estimated completion | 1 May 2024 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- DEFINITY — full drug profile →
- Sonalleve Focused Ultrasound Device
Conditions studied
- Head and Neck Cancer — all drugs for Head and Neck Cancer →
Sponsor
Sunnybrook Health Sciences Centre — full company profile →
Who can join
18 and older, any sex, with Head and Neck Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Theranostics in the vasculature: bioeffects of ultrasound and microbubbles to induce vascular shutdown.
Padilla F, Brenner J, Prada F, Klibanov AL. · · 2023 · cited 34× · PMID 37554276 · DOI 10.7150/thno.70372 -
Comprehensive review on ultrasound-responsive theranostic nanomaterials: mechanisms, structures and medical applications.
Tehrani Fateh S, Moradi L, Kohan E, Hamblin MR, et al · · 2021 · cited 24× · PMID 34476167 · DOI 10.3762/bjnano.12.64 -
Overview of Therapeutic Ultrasound Applications and Safety Considerations: 2024 Update.
Bader KB, Padilla F, Haworth KJ, Ellens N, et al · · 2025 · cited 23× · PMID 39526313 · DOI 10.1002/jum.16611 -
Radiation enhancement using focussed ultrasound-stimulated microbubbles for breast cancer: A Phase 1 clinical trial.
Moore-Palhares D, Dasgupta A, Saifuddin M, Anzola Pena ML, et al · · 2024 · cited 23× · PMID 38758967 · DOI 10.1371/journal.pmed.1004408 -
Involvement of Ceramide Signalling in Radiation-Induced Tumour Vascular Effects and Vascular-Targeted Therapy.
Sharma D, Czarnota GJ. · · 2022 · cited 21× · PMID 35743121 · DOI 10.3390/ijms23126671 -
Intravital imaging and cavitation monitoring of antivascular ultrasound in tumor microvasculature.
Zhao X, Pellow C, Goertz DE. · · 2023 · cited 20× · PMID 36593952 · DOI 10.7150/thno.79186 -
Ultrasound-Mediated Drug Delivery With a Clinical Ultrasound System: <i>In Vitro</i> Evaluation.
de Maar JS, Rousou C, van Elburg B, Vos HJ, et al · · 2021 · cited 19× · PMID 34737709 · DOI 10.3389/fphar.2021.768436 -
A study combining microbubble-mediated focused ultrasound and radiation therapy in the healthy rat brain and a F98 glioma model.
Fletcher SP, Chisholm A, Lavelle M, Guthier R, et al · · 2024 · cited 13× · PMID 38413663 · DOI 10.1038/s41598-024-55442-6
Verify or expand the search:
- PubMed search for NCT04431648
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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Other recruiting trials for Head and Neck Cancer
Currently open trials in the same condition.
- NCT07318220 — Prehabilitation Protocol for Head and Neck Cancer Patients · NA · recruiting
- NCT07524114 — Study of High-Precision Evaluation of Molecular ResiduaL Disease Through a PlatfOrm for Cancer TracKing and Interception · recruiting
- NCT07467083 — Development and Application of a Nurse-Led Preemptive Symptom Management Protocol for Head and Neck Cancer Patients Unde · Phase 3 · recruiting
- NCT07209189 — Neoadjuvant Chemotherapy and Programmed Cell Death Protein 1(PD-1) Inhibition for Head and Neck Cancer Treatment De-esca · Phase 2 · recruiting
- NCT06837480 — Photobiomodulation in Head and Neck Cancer-Related Chronic Lymphedema · NA · recruiting
Other Sunnybrook Health Sciences Centre trials
Trials by the same sponsor.
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- NCT07376018 — Ketogenic Diet and Neuromodulation in Treatment Resistant Depression · NA · not yet recruiting
- NCT07350278 — Comparing Virtual Reality Simulation to High Fidelity Simulation as an Educational Modality for Electroconvulsive Therap · NA · not yet recruiting
- NCT07191145 — Eary Infusion of Eptinezumab for TreatmEnt of ACute Post-Traumatic Headaches (ELITE-ACT) · Phase 3 · not yet recruiting
- NCT07308587 — Evaluation of Intercostal Neuralgia in Patients With Chest Tube Insertion After Traumatic Rib Fracture · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04431648 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sunnybrook Health Sciences Centre
- Last refreshed: 13 December 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04431648.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing