NCT04431674: USmBRT-B

Novel MRI-Guided Ultrasound Stimulated Microbubble Radiation Treatment for Patients With Chest-wall and Breast Cancer

Completed Phase 1 Last updated 13 December 2023

What this trial tests

Phase 1 trial testing Definity Suspension for Injection in Breast Cancer in 20 participants. Completed in 21 June 2023.

Timeline

22 July 2020

Primary endpoint
21 June 2023

21 June 2023

Quick facts

Lead sponsor	Sunnybrook Health Sciences Centre
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	22 July 2020
Primary completion	21 June 2023
Estimated completion	21 June 2023
Sites	1 location across Canada

Drugs / interventions tested

• Definity Suspension for Injection — full drug profile →

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Sunnybrook Health Sciences Centre — full company profile →

Who can join

18 and older, any sex, with Breast 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):

1. 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
2. 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
3. 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
4. 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
5. 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
6. 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
7. Novel MRI-guided focussed ultrasound stimulated microbubble radiation enhancement treatment for breast cancer.
   Dasgupta A, Saifuddin M, McNabb E, Ho L, et al · · 2023 · cited 19× · PMID 37604988 · DOI 10.1038/s41598-023-40551-5
8. 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