Molecular-Functional Imaging of Hypoxia in Childhood Sarcomas: Feasibility Steps Toward Personalized Medicine.
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Number of participants with response to therapy
研究概览
简要总结
This study will test the feasibility of using novel/existing imaging technologies focused on hypoxia measurements to determine "response to therapy" in pediatric soft tissue sarcomas as a pilot study. Specifically, the investigators will compare the sensitivity of Blood Oxygen Level Dependent [BOLD], Diffusion-Weighted [DW] MRI and Magnetic Resonance Spectroscopy (MRS) with that of conventional MRI to detect measurement changes between the start and completion of neoadjuvant therapy ("response to therapy") in children and adolescents (6-18 years) with suspicion of sarcoma tumors. Clinicians and scientists may use results of the proposed hypoxia-imaging surrogate markers to adjust/modify therapeutic schemes to patients on a personalized basis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Referred with a confirmed or suspected sarcoma tumor (rhabdomyosarcoma [RMS] or non-rhabdomyomatous sarcoma) presenting with an extra-osseous component;
- •Candidate for neoadjuvant therapy that will consist of standard systemic chemotherapy with or without radiation therapy
排除标准
- •Patients with general contraindications for an MRI scan (metal foreign body, pacemaker, inability to tolerate an examination without sedation);
- •Patients with a known immunodeficiency/sickle cell disease/collagen vascular disease/another malignancy;
- •Patients with no clinical indication for neoadjuvant therapy prior to surgery;
- •Patients with chronic pulmonary disease;
- •Patients with other diagnosis confirmed after initial suspicion of RMS or non-RMS.
研究组 & 干预措施
BOLD- DW- MRS
Blood Oxygen Level Dependent [BOLD], Diffusion-Weighted [DW] MRI, MR Spectroscopy [MRS]
干预措施: Blood Oxygen Level Dependent [BOLD] MRI (Diagnostic Test)
BOLD- DW- MRS
Blood Oxygen Level Dependent [BOLD], Diffusion-Weighted [DW] MRI, MR Spectroscopy [MRS]
干预措施: Diffusion-Weighted [DW] MRI (Diagnostic Test)
BOLD- DW- MRS
Blood Oxygen Level Dependent [BOLD], Diffusion-Weighted [DW] MRI, MR Spectroscopy [MRS]
干预措施: Magnetic Resonance Spectroscopy [MRS] (Diagnostic Test)
结局指标
主要结局
Number of participants with response to therapy
时间窗: 1 year
Response will be assessed by measurements of tumor volume, percentage of BOLD signal changes, percentage of tumor necrosis, apparent diffusion coefficient, concentration of high-energy and low-energy phosphates in tumor.
次要结局
- Associations between post-neoadjuvant therapy imaging measurements and surgical / histochemical outcomes in the residual tumor.(1 year)
研究者
Andrea Doria
Radiologist, Scientist, Research Director
The Hospital for Sick Children