Clinical trial · Interventional
Novel MRI-Guided Ultrasound Stimulated Microbubble Radiation Treatment for Patients With Chest-wall and Breast Cancer
Novel Magnetic Resonance Imaging -Guided Ultrasound-Stimulated Microbubble Radiation Treatment for Patients With Chest-Wall and Locally Advanced Breast Cancer
NCT04431674CI-TRIAL-00072190USmBRT-BcompletedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Definity Suspension for Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MRg-FUS MB Treatment
- description
- Patients with locally advanced breast cancer (LABC) and chest wall tumours will receive MRI-guided ultrasound-stimulated microbubble-treatment combined with radiotherapy on a LINAC.
- interventionNames
- Drug: Definity Suspension for Injection
Primary outcomes (1)
- measure
- Incidence of toxicity and adverse events using MRg-FUS+MB treatment in patients with chest-wall and locally advanced breast cancer
- timeFrame
- 90 days
- description
- Incidence of toxicity and adverse events
Secondary outcomes (1)
- measure
- Radiological Response
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years * All biopsy-confirmed invasive ductal, invasive lobular and other rare histologic types of carcinoma * Patients with early stage Breast cancer, or LABC ; i.e., Stage IIA - IIIC cancers (T2 N0 M0 to Any T, N3, M0) or Stage IV (Any T, Any N, M1) per AJCC guidelines (8th Edition) * Assessed by a multidisciplinary team of treating medical, surgical and radiation oncologist and found suitable for the treatment * Patient referred for palliative radiotherapy or standard radiotherapy, which may include any of the following dose regimens: 1) 20 Gy in 5 fractions, 2) 30 Gy in 10 fractions, 3) 40 Gy in 10 fractions, 4) 50 Gy in 20 fractions, 5) 60 Gy in 30 fractions and 6) 66 Gy in 33 fractions. * Able to understand and give informed consent * Weight \< 140 kg * Target lesion accessible for MRg-FU+MB procedure * Able to communicate sensation during the procedure * Creatinine within normal institutional limits or creatinine clearance \>60 mL/min/1.73 m2 for patients with creatinine levels above institutional upper limit of normal. 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 a contrast-enhanced MRI scan - standard of care criteria * Patients on anthracycline or taxane based chemotherapy * Patients with metallic or breast implants * Subjects with inflammatory breast cancer, connective tissue disorder, musculoskeletal deformity * Target lesion causing ulceration, bleeding or discharge of the overlying skin * A fibrotic scar along the proposed FU beam path * Severe cardiovascular, neurological, renal or hematological chronic disease * Eastern Cooperative Oncology Group (ECOG) Performance Status ≥ 3 * Any condition in the investigator's opinion precludes participation * Bleeding disorders/ High risk for deep vein thrombosis * Unable to tolerate required stationary position during treatment * Allergic to Definity microbubbles * 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) * History of bleeding disorder, coagulopathy * Severely impaired renal function with estimated glomerular filtration rate \< 30ml/min/1.73m2 and/or on dialysis
References
Publications (2)
- DERIVEDMoore-Palhares D, Dasgupta A, Saifuddin M, Anzola Pena ML, Prasla S, Ho L, Lu L, Kung J, McNabb E, Sannachi L, Vesprini D, Chen H, Karam I, Soliman H, Szumacher E, Chow E, Gandhi S, Trudeau M, Curpen B, Stanisz GJ, Kolios M, Czarnota GJ. Radiation enhancement using focussed ultrasound-stimulated microbubbles for breast cancer: A Phase 1 clinical trial. PLoS Med. 2024 May 17;21(5):e1004408. doi: 10.1371/journal.pmed.1004408. eCollection 2024 May. PMID 38758967
- DERIVEDDasgupta A, Saifuddin M, McNabb E, Ho L, Lu L, Vesprini D, Karam I, Soliman H, Chow E, Gandhi S, Trudeau M, Tran W, Curpen B, Stanisz G, Sahgal A, Kolios M, Czarnota GJ. Novel MRI-guided focussed ultrasound stimulated microbubble radiation enhancement treatment for breast cancer. Sci Rep. 2023 Aug 21;13(1):13566. doi: 10.1038/s41598-023-40551-5. PMID 37604988