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

NCT04431674 | Completed Phase 1 DMC

• 1 other identifier: 077-2019
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer

Keywords

Breast Cancer; Focused ultrasound; Microbubbles

Outcome Measures

Primary Outcomes (1)

• Incidence of toxicity and adverse events using MRg-FUS+MB treatment in patients with chest-wall and locally advanced breast cancer

  Incidence of toxicity and adverse events

  90 days

Secondary Outcomes (1)

• Radiological Response

  90 days

Study Arms (1)

MRg-FUS MB Treatment

EXPERIMENTAL

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.

Drug: Definity Suspension for Injection

Interventions

Definity Suspension for Injection DRUG

MRI-guided ultrasound-stimulated microbubble-treatment

MRg-FUS MB Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (2)

• 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.

  PMID: 38758967 DERIVED

• 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.

  PMID: 37604988 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Injections

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Dr. Gregory Czarnota, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist, MD

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

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: June 16, 2020
• Study Start: July 22, 2020
• Primary Completion: June 21, 2023
• Study Completion: June 21, 2023
• Last Updated: December 13, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)