跳至主要内容
临床试验/NCT03053960
NCT03053960终止不适用

Predictability of Carcinomatous Invasion of the Maxilla or Mandible: An Assessment of Radiologic Modalities With Histologic Correlation

Sidney Kimmel Cancer Center at Thomas Jefferson University0 个研究点目标入组 8 人开始时间: 2015年11月24日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
8
主要终点
Accurate Predication of the Presence or Absence of Bone Invasion by Oral Squamous Cell Carcinoma by Helical CT, PET/CT, MRI and CBCT

研究概览

简要总结

This clinical trial studies how well helical computed tomography (CT), positron emission tomography (PET)/CT, magnetic resonance imaging (MRI), and cone beam computed tomography (CBCT) work alone or in combination in predicting whether tumor cells have spread to the jaw bone (jaw invasion) in patients with oral cancer. Imaging, such as helical CT, PET/CT, MRI, and CBCT, may help find out how far cancer has spread. Accurate prediction of the presence or absence of jaw invasion may help create a better surgical treatment plan for patients with oral cancer.

详细描述

PRIMARY OBJECTIVES:

I. To determine which imaging modality or combination of imaging methods, in conjunction with clinical and histological examination, will most accurately predict the presence or absence of invasion of the mandible or maxilla by intraoral squamous cell carcinoma (SCC).

SECONDARY OBJECTIVES:

I. To compare the histopathologic findings to the radiologic findings.

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of squamous cell carcinoma of the oral cavity
  • Able to read and sign and informed consent

排除标准

  • Prior mandibular surgery
  • Primary intraosseous carcinoma
  • Prior history of radiation to the mandible
  • Obvious finding of clinical invasion of the mandible

结局指标

主要结局

Accurate Predication of the Presence or Absence of Bone Invasion by Oral Squamous Cell Carcinoma by Helical CT, PET/CT, MRI and CBCT

时间窗: Up to 2 years

Sensitivity and specificity of the clinical exam, CBCT, helical CT, PET/CT, MRI and any other imaging modality used in detection of bone invasion will be calculated, as compared to the histological examination of the specimens. The positive and negative predictive value will be calculated for each modality using the true positive and negatives as well as false positive and negative values

次要结局

  • Incidence of Sparing Resection(Up to 2 years)

研究者

申办方类型
Other
责任方
Sponsor

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