A Phase II Trial of Reflectance ConfocaL Microscopy And Optical Coherence Tomography Guided RadIation TherapY: CLARITY
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 38
- 试验地点
- 13
- 主要终点
- histologic tumor response rate
研究概览
简要总结
The purpose of this study is to find out if radiation therapy (RT) guided by the new reflectance confocal microscopy (RCM)/optical coherence tomography (OCT) device is an effective treatment for basal cell carcinoma (BCC). The researchers will also look at the side effects from RT guided by the RCM/OCT device. In addition, will determine the quality of life before and after treatment by having the participant fill out questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Biopsy proven basal cell carcinoma
- •°Up to 3 tumors per patient can be treated per protocol synchronously or metachronously
- •Clinical stage T1 or T2 by Union International to Control Cancer 8th edition system
- •≤40 mm in maximum dimension
- •no deep invasion (beyond subcutaneous fat or >6 mm from granular later of dermis to deepest point of carcinoma)
- •no perineural invasion of nerves ≥0.1 mm diameter or deeper than dermis
- •no intraneural invasion
- •no bone erosion, invasion or foraminal transgression NOTE: For the purposes of protocol inclusion, if any of the features mentioned above is not included in the pathology report they will considered absent.
- •≥18 years old
- •Amenable to RCM/OCT and radiation therapy in opinion of investigator
- •Some anatomic locations may preclude imaging by RCM/OCT may not be amenable to RCM/OCT imaging
- •Some medical comorbidities may preclude the delivery of radiation therapy (conditions rendering patients hypersensitive to ionizing radiation, or unable to undergo treatment)
- •Able and willing to complete the Skindex 16 and Skin Cancer Index (must be able to understand English or Spanish)
排除标准
- •Medical contraindication to radiation therapy in the opinion of the investigator
- •Prior cancer radiotherapy which precludes the ability to safely deliver radiation therapy in the opinion of the investigator
- •High likelihood of protocol non-compliance in the opinion of the investigator °Patients who demonstrate unwillingness to undergo protocol-defined treatment or follow-up procedures will be ineligible to participate
研究组 & 干预措施
Reflectance ConfocaL Microscopy And Optical Coherence Tomography Guided RadIation Therapy
If eligible, patients will undergo pretreatment RCM/OCT imaging, followed by RT.
Six weeks after the completion of RT, patients will undergo post-treatment assessment with RCM/OCT and biopsy. If residual carcinoma is detected on the biopsy, surgical excision of the BCC will be performed. If no residual carcinoma is detected on the biopsy, the patient will be monitored for clinical evidence of recurrence for up to 3 years.
干预措施: Reflectance ConfocaL Microscopy And Optical Coherence Tomography Guided (Device)
Reflectance ConfocaL Microscopy And Optical Coherence Tomography Guided RadIation Therapy
If eligible, patients will undergo pretreatment RCM/OCT imaging, followed by RT.
Six weeks after the completion of RT, patients will undergo post-treatment assessment with RCM/OCT and biopsy. If residual carcinoma is detected on the biopsy, surgical excision of the BCC will be performed. If no residual carcinoma is detected on the biopsy, the patient will be monitored for clinical evidence of recurrence for up to 3 years.
干预措施: Radiation Therapy (Radiation)
结局指标
主要结局
histologic tumor response rate
时间窗: 6 weeks
The presence of residual carcinoma on a biopsy or surgical excision specimen will be primary determinant for the primary endpoint outcome.
次要结局
- frequency and severity of adverse events(up to 12 weeks)