Optical Biopsy to Improve the Diagnosis of Kidney Cancer: a Prospective, Observational, Multicentre, In-vivo Study
试验速览
- 阶段
- 不适用
- 入组人数
- 194
- 试验地点
- 2
- 主要终点
- The sensitivity and specificity of DRS and OCT in the detection of renal malignancy
研究概览
简要总结
Data from the American Cancer Society shows a 70% increase in incidence of kidney and renal pelvis cancer between 2000 and 2010. This increase is attributed to small renal masses (SRM) that are incidentally discovered by abdominal radiological imaging. However, 30% of resected SRMs appear benign on histological examination. Conventional biopsy is currently used to provide pathological information prior to resection. However, its non-diagnostic value is high, up to 33% in SRMs, showing the need for diagnostic improvement.
The investigators have shown that optical biopsy (OB) can differentiate malignant from benign tissue and tumor subtypes. However, translation to the clinic requires a phase 2 clinical study. The investigators will use an OB probe that can be combined with a needle puncture during classical biopsy procedures, additionally providing real time micro-scale images containing quantitative information about tissue properties. The investigators are convinced that OB will greatly improve the diagnosis of renal tumor pathology.
详细描述
Rationale:
Renal biopsies can be used in patients with renal mass lesions to diagnose whether it concerns a malignant or benign mass. In case of malignancy, surgery will be the following step. However, 7 to 33% of biopsies are non-diagnostic, what can result in unnecessary surgery (even up to 30% in small renal masses). The investigators think that optical biopsy (OB), a new diagnostic tool based on the absorption en reflection of light in tissues, reduces the non-diagnostic biopsy rate. This could have a direct impact on the quality of life of the patients that are therefore scheduled for an unnecessary surgical procedure. Also, concerns about overtreatment have led to the concept of focal therapy, a selective patient tailored nephron sparing surgical or ablation technique of a lesion, reducing lifetime morbidity and side effects without compromising life expectancy. For this novel form of treatment, accurate identification, grading and demarcation of a lesion is crucial and OB is the ideal platform to provide this approach to an improved cure.
Objectives:
Primary
- The accuracy of DRS and OCT in the diagnostic of renal malignancy
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Solid, enhancing mass on cross sectional imaging suspect for RCC
- •Scheduled for total or partial nephrectomy or for laparoscopic cryoablation.
- •Signed informed consent
排除标准
- •Patients with a renal mass that are not candidates for active treatment will be excluded from the study
结局指标
主要结局
The sensitivity and specificity of DRS and OCT in the detection of renal malignancy
时间窗: Participants will undergo OCT/DRS measurements within 2 weeks after inclusion
By measuring the OCT attenuation coefficient (µOCT) and the DRS optical blood absorption (µaHb), and correlating these values to the histopathology results.
次要结局
- The sensitivity and specificity of DRS and OCT in differentiating between the three main RCC subtypes(Participants will undergo OCT/DRS measurements within 2 weeks after inclusion)
研究者
P.G.K. Wagstaff
MD.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)