Multimodal Imaging for Surveillance of Patients With Oral Potentially Malignant Disorders
试验速览
- 阶段
- 早期 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Detection of high grade dysplasia and carcinoma
研究概览
简要总结
This early phase I trial studies how well multimodal imaging works for surveillance in patients with oral potentially malignant disorders. New types of imaging devices may help doctors decide if a lesion in the mouth is pre-cancerous or cancerous.
详细描述
PRIMARY OBJECTIVES:
I. To compare standard white light examination to multimodal imaging for detection of high grade dysplasia and carcinoma during follow-up examinations of patients with oral potentially malignant disorders (OPMD).
SECONDARY OBJECTIVES:
I. To determine qualitative and quantitative diagnostic assessment of patients who agree to undergo imaging and have images of sufficient quality.
II. To compare expression of molecular biomarkers to results from white light examination, multimodal imaging and pathologic assessment in a subset of patients who have invasive biopsies or resection.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who are willing to participate.
- •Adult subjects with: a. clinically evident oral premalignant lesion (OPL) or suspicious oral mucosal lesion. or b. pathologic diagnosis of dysplasia or c. history of resected oral cancer or d. oral potentially malignant disorder (OPMD) or e. history of tobacco and/or alcohol exposure.
- •Ability to understand and willingness to sign a written informed consent document (ICD).
排除标准
- •Known allergy to proflavine or acriflavine.
- •Pregnant females.
研究组 & 干预措施
Diagnostic (multimodal imaging, biopsy)
Participants undergo PS2.1/PS3 imaging and high-resolution microendoscope imaging with proflavine hemisulfate applied to the mucosa. Patients also undergo brush biopsy and incisional biopsy. Procedures are repeated every 3-4 months for 2 years.
干预措施: Biopsy (Procedure)
Diagnostic (multimodal imaging, biopsy)
Participants undergo PS2.1/PS3 imaging and high-resolution microendoscope imaging with proflavine hemisulfate applied to the mucosa. Patients also undergo brush biopsy and incisional biopsy. Procedures are repeated every 3-4 months for 2 years.
干预措施: Fluorescence Imaging (Procedure)
Diagnostic (multimodal imaging, biopsy)
Participants undergo PS2.1/PS3 imaging and high-resolution microendoscope imaging with proflavine hemisulfate applied to the mucosa. Patients also undergo brush biopsy and incisional biopsy. Procedures are repeated every 3-4 months for 2 years.
干预措施: High-Resolution Microendoscopy (Procedure)
Diagnostic (multimodal imaging, biopsy)
Participants undergo PS2.1/PS3 imaging and high-resolution microendoscope imaging with proflavine hemisulfate applied to the mucosa. Patients also undergo brush biopsy and incisional biopsy. Procedures are repeated every 3-4 months for 2 years.
干预措施: Proflavine Hemisulfate (Drug)
结局指标
主要结局
Detection of high grade dysplasia and carcinoma
时间窗: Up to 2 years
Will compare standard white light examination to multimodal imaging for detection of high grade dysplasia and carcinoma during follow-up examinations of patients with oral potentially malignant disorders (OPMD).
次要结局
- Diagnostic assessment(Up to 2 years)
- Biomarker analysis(Up to 2 years)
- Cytologic results(Up to 2 years)