Quantitative Imaging Tools to Derive DW-MRI Oncological Biomarkers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- For group 1: number of patients that have biomarkers that maybe early response to therapy indicators
研究概览
简要总结
Magnetic resonance imaging (MRI) is a diagnostic technique that takes pictures of organs of the body. It uses magnetic fields and radio waves that cannot be felt. This makes specific organs, blood vessels, or tumors easier to see. Diffusion MRI lets us measure the motion of water in the tumor.
The purpose of this study is to see if new MRI methods can give us more information about the tumor.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Group 1 patients: Presence of a suspicious metastatic lesion or suspicious for recurrent disease in the head and neck region.
- •Group 2 patients:
- •Biopsy proven recurrent or metastatic or definitive head and neck cancer or (differentiated and undifferentiated) thyroid cancers in the head and neck region only.
- •Patients planning to undergo reatment at MSK
排除标准
- •Patient would require anesthesia for the study
- •Patients who are claustrophobic
- •Patients selecting treatment outside of MSK
- •Known reaction to Gd based contrast agent
- •Patients who have presence of a known contradiction to MRI
- •Pacemaker
- •Aneurysm clips
- •Patients with implants that are contradicted for MR imaging will be excluded
- •Age and mental status wherein he /she is unable to cooperate for MRI study
研究组 & 干预措施
recurrent or metastatic head and neck cancer patients
Patients will be imaged on a 1.5 T or 3 T MR scanner. Patients will receive a test-retest DWI scan in on session prior to start of treatment. Patients who will be receiving radiation therapy treatment at Memorial Sloan Kettering's main campus, will also be imaged weekly during their course of treatment.
干预措施: MRI examinations (Other)
head and neck cancer or thyroid cancers (differentiated and undifferentiated)
All patients, irrespective of treatment regimen, will be imaged on a 1.5T or 3T MR scanner prior to treatment initiation. Follow up imaging for patients undergoing surgery only will be as per clinical standard of care and not on this protocol. Patients undergoing treatment in radiation oncology and/or medicine will have imaging studies during week 2 of treatment. If patients receive 70Gy, they will also receive a scan during week 4 of treatment, if needed by treating physician. Scans will be performed to derive MRI biomarkers indicative of therapeutic mechanisms of action or efficacy will also be performed.
干预措施: MRI examinations (Other)
结局指标
主要结局
For group 1: number of patients that have biomarkers that maybe early response to therapy indicators
时间窗: 1 year
The study is designed to determine if the MRI will provide quantitative imaging biomarkers to predict or assess early treatment response in R/M head and neck cancers. The MR data will be compared with clinical follow-up data. Additional sequence parameters.
For group 2: number of patients response to treatment
时间窗: 1 year
will be assessed using ROC curves with RECIST with the RECIST version 1.1 response as the gold standard and change in DW-MRI and image feature metrics as predictors.
次要结局
未报告次要终点