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

NCT ID: NCT04431674

Last Updated: 2023-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-22

Study Completion Date

2023-06-21

Brief Summary

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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.

Detailed Description

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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. 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 chest wall and breast 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.

Conditions

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Breast Cancer

Keywords

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Breast Cancer Focused ultrasound Microbubbles

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective, Single-Centre, Single-Arm, Non-Randomized, Phase-I MRI-Guided Ultrasound Stimulated Microbubbles Radiation Treatment for Patients with Chest Wall and Breast Cancer
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MRg-FUS MB Treatment

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.

Group Type EXPERIMENTAL

Definity Suspension for Injection

Intervention Type DRUG

MRI-guided ultrasound-stimulated microbubble-treatment

Interventions

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Definity Suspension for Injection

MRI-guided ultrasound-stimulated microbubble-treatment

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sunnybrook Health Sciences Centre

OTHER

Sponsor Role lead

Responsible Party

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Dr. Gregory Czarnota

Senior Scientist, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dr. Gregory Czarnota, MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Locations

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Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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Moore-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.

Reference Type DERIVED
PMID: 38758967 (View on PubMed)

Dasgupta 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.

Reference Type DERIVED
PMID: 37604988 (View on PubMed)

Other Identifiers

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077-2019

Identifier Type: -

Identifier Source: org_study_id