Magnetic Resonance-Guided High Intensity Focused Ultrasound for Recurrent Rectal Cancer - A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Acute toxicities
研究概览
简要总结
This pilot study hypothesizes that hyperthermia delivered via magnetic resonance-guided focused ultrasound (MRg-FU) is technically feasible and can be safely used in combination with concurrent reirradiation and chemotherapy for the treatment of recurrent rectal cancer. Twenty recurrent rectal cancer patients who are not candidates for surgery will be recruited for hyperthermia treatment delivered via MRg-FU concurrent with reirradiation and oral chemotherapy.
详细描述
Magnetic resonance-guided focused ultrasound (MRg-FU) is a non-invasive, outpatient modality being investigated for the thermal treatment of cancer. In MRg-FU, a specially designed transducer is used to focus a beam of low intensity ultrasound energy into a small volume at a specific target site in the body. MR is used to identify and delineate the tumour, focus the ultrasound beam on the target and provide real-time thermal mapping to ensure accurate heating of the designated target with minimal effect to the adjacent healthy tissue. The focused ultrasound beam produces therapeutic hyperthermia (40-42°C) in the target field causing protein denaturation and cell damage.
Currently, there is no prospective clinical data reported on the use of MRg-FU in the setting of recurrent rectal cancer. Recurrent rectal cancer is a vexing clinical problem. Current retreatment protocols have limited efficacy. The addition of hyperthermia to radiation and chemotherapy may enhance the therapeutic response. With recent advances in technology, the investigators hypothesize that MRg-FU is technically feasible and can be safely used in combination with concurrent reirradiation and chemotherapy for the treatment of recurrent rectal cancer without increased side-effects.
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
- •Able to give informed consent
- •Weight <140kg
- •Biopsy-proven recurrent rectal adenocarcinoma
- •Assessed by the treating surgeon, medical oncologist and radiation oncologist, and following a multidisciplinary discussion, determined to have unresectable and/or inoperable disease in the presence or absence of distant metastases
- •Assessed by the treating radiation oncologist and medical oncologist determined to be fit for reirradiation and chemotherapy
- •Prior pelvic radiotherapy
- •Target lesion visible by MR
- •Target lesion accessible for MRg-FU procedure
- •Target lesion maximum dimension ≤ 6cm
- •Able to communicate sensation during MRg-FU treatment
排除标准
- •Abdominal or pelvic surgery (excluding biopsy) ≤ 6 weeks prior to study enrolment
- •Chemotherapy or other systemic anti-cancer agent ≤ 6 weeks prior to enrolment
- •Previous radiotherapy ≤ 6 weeks prior to enrolment
- •Recurrent tumour involves small bowel
- •Unable to characterize pain
- •Pregnant / Nursing woman
- •Orthopaedic implant along proposed MRg-FU beam path or at site of target lesion.
- •Serious cardiovascular, neurological, renal or hematological chronic disease
- •Active infection
- •Unable to tolerate required stationary position during treatment
- •Allergy to MR contrast agent or sedation
研究组 & 干预措施
MRg-FU
Hyperthermia via magnetic resonance-guided focused ultrasound will be administered once per week for three weeks concurrent with standard radiation and chemotherapy.
干预措施: Magnetic resonance-guided focused ultrasound (Device)
MRg-FU
Hyperthermia via magnetic resonance-guided focused ultrasound will be administered once per week for three weeks concurrent with standard radiation and chemotherapy.
干预措施: Standard Radiation (Radiation)
MRg-FU
Hyperthermia via magnetic resonance-guided focused ultrasound will be administered once per week for three weeks concurrent with standard radiation and chemotherapy.
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Acute toxicities
时间窗: 3 months
Gastrointestinal and genitourinary toxicities assessed as per Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0 after each MRg-FU treatment and 30, 60 and 90 days post-treatment.
次要结局
- Patient quality of life(3 years)
- Late toxicities(3 years)
- Assessment of radiologic response following treatment.(3 years)
- The efficacy of MRg-FU in reducing pain(3 years)
研究者
William Chu, MD, MSc, FRCPC
Radiation Oncologist, Clinician Investigator
Sunnybrook Health Sciences Centre