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临床试验/NCT04750434
NCT04750434已完成不适用

PET MRI as a Staging Tool for Head and Neck Cancer

Hoag Memorial Hospital Presbyterian1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年3月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
PET MRI as a Staging Tool for Head and Neck Cancer

研究概览

简要总结

To explore the use of PET/MRI in the staging and pretreatment evaluation of patients with head and neck cancer and to compare this modality to standard PET/CT imaging.

详细描述

This study is a prospective clinical study whereby an emerging technology, PET/MRI will be compared to a more standard imaging modality, PET/CT, using newly diagnosed head and neck cancer patients as subjects. PET/MRI will also be used in this study to explore the merits of this new technology in determining extent of disease, functional impact, and potential treatment outcome.

In this study, subjects suitable for enrollment will be identified by the investigators involved in the study. These subjects will be identified through contact with these investigators and referred for enrollment per protocol. This protocol will include determining enrollment suitability based on inclusion and exclusion criteria. Once accepted as a candidate for the study, the newly diagnosed head and neck cancer patients will undergo both PET/CT and PET/MRI imaging within one week of each other. These studies will then be reviewed by a radiologist specializing in Head and Neck radiology familiar with PET imaging. The studies will be compared for any imaging differences. The imaging findings will then be correlated with pathological findings after surgery to determine if there are any consistent findings that correlate with adverse pathological findings, if found.

The specific imaging data points to be determined by a radiologist will be tumor and metastatic disease size, SUV uptake, specific anatomic structures involved with tumor, imaging irregularities and characteristics of those imaging irregularities of the involved structures locally and regionally (if present), imaging characteristics of the different phases of MRI (T1, T2, etc.), and any other notable imaging characteristic.

研究设计

研究类型
Observational
观察模型
Case Crossover
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

入选标准

  • Active head and neck cancer that require PET/CT regardless of the point of treatment
  • TNM staging I or II

排除标准

  • Patients whose primary treatment option is chemotherapy or radiation therapy (not surgical)
  • Implanted pacemakers
  • Intracranial aneurysm clips
  • Cochlear implants
  • Certain prosthetic devices
  • Implanted drug infusion pumps
  • Neurostimulators
  • Bone-growth stimulators
  • Certain intrauterine contraceptive devices; or
  • Any other type of iron-based metal implants.
  • MRI should not also be used on persons with the presence of internal metallic objects such as bullets or shrapnel, as well as surgical clips, pins, plates, screws, metal sutures, or wire mesh.
  • Subject with breast tissue expanders.

结局指标

主要结局

PET MRI as a Staging Tool for Head and Neck Cancer

时间窗: 18 months

Outcomes from this study will include a comparison of PET/MRI with PET/CT directly in a series of patients where surgical pathology specimens are available for correlation.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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