Pilot Study of Metabolic Guidance for Therapy in Patients With Thyroid Cancer and Other Malignancies of the Head and Neck
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Metabolic imaging data from hyperpolarized magnetic resonance imaging (hpMRI) methods
研究概览
简要总结
This trial investigates whether hyperpolarized magnetic resonance imaging (hpMRI) can predict treatment response in patients with thyroid cancer and other malignancies of the head and neck undergoing radiation therapy and/or receiving systemic therapy before surgery. An hpMRI is like a standard MRI but involves the use of an imaging contrast agent called hyperpolarized 13-C-pyruvate. Diagnostic procedures, such as hpMRI, may predict a patient's response to treatment and may help plan the best treatment.
详细描述
PRIMARY OBJECTIVE:
I. To obtain pilot metabolic imaging data from hyperpolarized magnetic resonance imaging (hpMRI) methods in patients with thyroid tumors or other malignancies of the head and neck receiving radiation therapy (XRT) and/or systemic therapy (e.g., target therapy, checkpoint inhibitors).
SECONDARY OBJECTIVE:
I. To assess early metabolic changes in response to nonsurgical therapy, including standard-of-care fractionated XRT and/or systemic therapy.
OUTLINE: Participants are assigned to 1 of 2 arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- 是
入选标准
- •Be willing and able to provide informed consent
- •Be informed of the investigational nature of this study
- •Be diagnosed with thyroid cancer and other malignancies of the head and neck with intent for treatment
排除标准
- •Have a history of severe claustrophobia
- •Have electrically, magnetically or mechanically activated implants that would preclude magnetic resonance imaging (MRI)
- •Have a history of cardiac arrhythmia
- •Have an allergy to Gadavist intravenous contrast
- •Estimated glomerular filtration rate (eGFR) < 30
- •If female, be pregnant or breast feeding at time of consent
研究组 & 干预措施
Arm I ( Health Volunteer MRI)
Healthy volunteers undergo MRI over 30 minutes.
干预措施: Magnetic Resonance Imaging (Procedure)
Arm II (Thyroid Cancer Patient and other malignancies of the head and neck hpMRI)
Patients with thyroid cancer and other malignancies of the head and neck undergo hpMRI over 30 minutes at baseline, and at 1 week after the initiation of treatment. During the scan, patients also receive hyperpolarized 13-C-pyruvate IV over 30 seconds and may receive a standard MRI contrast agent at the discretion of the treating physician.
干预措施: Hyperpolarized Carbon C 13 Pyruvate (Drug)
Arm II (Thyroid Cancer Patient and other malignancies of the head and neck hpMRI)
Patients with thyroid cancer and other malignancies of the head and neck undergo hpMRI over 30 minutes at baseline, and at 1 week after the initiation of treatment. During the scan, patients also receive hyperpolarized 13-C-pyruvate IV over 30 seconds and may receive a standard MRI contrast agent at the discretion of the treating physician.
干预措施: Magnetic Resonance Imaging (Procedure)
结局指标
主要结局
Metabolic imaging data from hyperpolarized magnetic resonance imaging (hpMRI) methods
时间窗: 1 year
To measure metabolic imaging data or information derived from hyperpolarized pyruvate MRI (hpMRI) that can be used to identify an early indication of response to therapy in patients with thyroid cancer. Specifically, we measure the kPL-the apparent rate constant for conversion of HP pyruvate into lactate-after one week of treatment compared to baseline measurements acquired prior to start of therapy. The kPL will be calculated from dynamic images of HP pyruvate and its metabolites. The kPL values will be calculated for each tumor and its adjacent tissue by a radiologist and physicist in conjunction using region of interest analysis to identify the margins of the tumor and surrounding normal tissue.
次要结局
- Early metabolic changes(1 year)