A Prospective, Single-Centre, Single-Arm, Non-Randomized, Phase-I, MRI-Guided Ultrasound Stimulated Microbubbles Radiation Treatment for Patients with Chest-Wall and Locally Advanced Breast Cancer - a Pilot Study
概览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Safety profile of MRI- guided ultrasound stimulated microbubble treatment and radiation in patients with inoperable breast/chest wall tumours or LABC.
概览
简要总结
The objective of this study is to demonstrate the feasibility of novel Magnetic Resonance Imaging (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.
详细描述
This is a prospective, single-centre, single-arm, non-randomized phase one (Phase I) clinical trial. In this study, locally advanced breast cancer (LABC) and breast/chest wall tumours not managed by surgery, patients will receive MRI-guided ultrasound-stimulated microbubble-treatment using an Arrayus MRI-FUS System combined with radiotherapy on a LINAC. Patients will lie on the MRI table with an in-built focused ultrasound platform where the tumour is kept in close contact with the transducer of the ultrasound. After exposure to the tumour with focused ultrasound, the patient will receive a standard of care LINAC-based radiation therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 as indicated, by a multidisciplinary team of treating medical, surgical and radiation oncologist and found suitable for radiation treatment.
- •Patient referred for standard palliative radiotherapy or curative radiotherapy, which may include (but are not limited to) any of the following dose regimens: 1) 5-8 Gy in one fraction, 2) 20 Gy in 5 fractions, 3) 30 Gy in 5 fractions, 4) 35 Gy in 5 fractions, 5) 30 Gy in 10 fractions, 6) 40 Gy in 10 fractions, 5) 50 Gy in 20 fractions, 6) 60 Gy in 30 fractions and 7) 66 Gy in 33 fractions, or radiobiologically similar doses.
- •Able to understand and give informed consent.
- •Weight \< 140 kg.
- •Target lesion accessible for MRg-FUS+MB procedure.
- •Able to communicate sensation during the procedure.
- •Creatinine within normal institutional limits or creatinine clearance \>60mL/min/ Novel MRI-Guided Ultrasound Stimulated Microbubble Radiation Treatment for Patients with Chest-Wall and Locally Advanced Breast Cancer. 1.73m2 for patients with creatinine levels above institutional upper limit of normal.
排除标准
- •Pregnant or lactating women may not participate due to the embryotoxic effects of protocol treatment.
- •Unable to have a contrast-enhanced MRI scan - standard of care criteria.
- •Patients having received anthracycline or taxane based chemotherapy within the past 5 days.
- •Patients with metallic or breast implants.
- •Subjects with connective tissue disorder, musculoskeletal deformity.
- •Target lesion causing deep ulceration, bleeding or discharge of the overlying skin.
- •A fibrotic scar along the proposed FUS beam path.
- •Severe cardiovascular, neurological, renal or hematological chronic disease.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status ≥
- •Any condition that in the investigator's opinion precludes participation.
研究组 & 干预措施
Treatment Arm
All biopsy confirmed breast cancer patients undergoing MRI-Ultrasound Stimulated Microbubble Radiation Treatment plus Radiation Therapy.
干预措施: MR-Guided Focused Ultrasound Technology (Device)
Treatment Arm
All biopsy confirmed breast cancer patients undergoing MRI-Ultrasound Stimulated Microbubble Radiation Treatment plus Radiation Therapy.
干预措施: Definity Suspension for Injection (Drug)
结局指标
主要结局
Safety profile of MRI- guided ultrasound stimulated microbubble treatment and radiation in patients with inoperable breast/chest wall tumours or LABC.
时间窗: 2 years
The primary aim of this research is to evaluate the safety profile of MRI- guided ultrasound stimulated microbubble treatment and radiation in patients with inoperable breast/chest wall tumours or LABC.Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
次要结局
- Tumour size response to MRg-FUS + MB and radiation, as measured radiologically or clinically within the treated therapeutic regions.(2 years)