Assessing a Biomarker Platform for Stratifying Indeterminate Pulmonary Nodules - The SPOT IT Platform Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 400
- 试验地点
- 7
- 主要终点
- Appropriate nodule management
研究概览
简要总结
This clinical trial studies whether a biomarker platform, the Virtual Nodule Clinic, can be used for the management of lung (pulmonary) nodules that are not clearly non-cancerous (benign) or clearly cancerous (malignant) (indeterminate pulmonary nodules [IPNs]). The management of IPNs is based on estimating the likelihood that the observed nodule is malignant. Many things, such as age, smoking history, and current symptoms, are considered when making a prediction of the likelihood of malignancy. Radiographic imaging characteristics are also considered. Lung nodule management for IPNs can result in unnecessary invasive procedures for nodules that are ultimately determined to be benign, or potential delays in treatment when results of tests cannot be determined or are falsely negative. The Virtual Nodule Clinic is an artificial intelligence (AI) based imaging software within the electronic health record which makes certain that identified pulmonary nodules are screened by clinicians with expertise in nodule management. The Virtual Nodule Clinic also features an AI based radiomic prediction score which designates the likelihood that a pulmonary nodule is malignant. This may improve the ability to manage IPNs and lower unnecessary invasive procedures or treatment delays. Using the Virtual Nodule Clinic may work better for the management of IPNs.
详细描述
PRIMARY OBJECTIVES:
I. To test the hypothesis that usual care plus a radiomic prediction score impacts patient management compared to usual care alone.
II. To conduct a multicenter pragmatic randomized controlled platform trial using a validated biomarker, the radiomic prediction score.
III. To conduct a biomarker study that will evaluate the first necessary (but not sufficient) step to show clinical utility.
IV. To assess the magnitude of change in patient management with use of the radiomic prediction score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 35-year-old and older with undiagnosed IPN(s) 8-30mm referred for evaluation
- •Referral includes direct in-basket messages in the electronic healthcare record (EHR) to study providers, telehealth visits or clinic visit
- •For multiple nodules, we will obtain the score from the dominant or most suspicious nodule based on providers or radiologist impression
- •Available CT scan with slice thickness of 3 mm or less with the nodule of interest present. Nodules identified during screening low dose computed tomography of the chest (LDCT) that have had a conventional, follow-up CT performed are eligible for inclusion
排除标准
- •Pure ground glass nodule
- •Patients known to be a prisoners
- •Patients known to be pregnant
- •Known active malignancy within the last 5 years at time of enrollment (excluding non-melanoma skin cancers)
- •More than 5 IPNs present on imaging
- •Nodules referred after initial LDCT for screening with only one LDCT available. The Lung Cancer Prediction Convolutional Neural Network (LCP CNN) algorithm is not currently validated for screening studies
- •Thoracic implants that impact the image appearance of the nodule
- •Clinician determines that use of the LCP CNN model is required or contraindicated for the optimal care of the patient
研究组 & 干预措施
Arm I (Radiomic Prediction Score)
Patients undergo SOC CT evaluation and receive a Virtual Nodule Clinic radiomic prediction score on study. Patients then receive SOC lung nodule management on study.
干预措施: Computed Tomography (Procedure)
Arm I (Radiomic Prediction Score)
Patients undergo SOC CT evaluation and receive a Virtual Nodule Clinic radiomic prediction score on study. Patients then receive SOC lung nodule management on study.
干预措施: Diagnostic Procedure (Device)
Arm I (Radiomic Prediction Score)
Patients undergo SOC CT evaluation and receive a Virtual Nodule Clinic radiomic prediction score on study. Patients then receive SOC lung nodule management on study.
干预措施: Best Practice (Other)
Arm I (Radiomic Prediction Score)
Patients undergo SOC CT evaluation and receive a Virtual Nodule Clinic radiomic prediction score on study. Patients then receive SOC lung nodule management on study.
干预措施: Electronic Health Record Review (Other)
Arm II (Usual Care)
Patients undergo SOC CT evaluation on study. Patients then receive SOC lung nodule management on study.
干预措施: Computed Tomography (Procedure)
Arm II (Usual Care)
Patients undergo SOC CT evaluation on study. Patients then receive SOC lung nodule management on study.
干预措施: Best Practice (Other)
结局指标
主要结局
Appropriate nodule management
时间窗: Up to 1 Year
Will be defined as referral for imaging surveillance for ultimately benign nodules, and biopsy, positron emission tomography scan, surgery or empiric stereotactic body radiation therapy for malignant nodules. Standard consort diagram will be created. Descriptive statistics including means, standard deviations, and median and interquartile ranges for continuous parameters, as well as percentages and frequencies for categorical parameters will be presented. Will compare the proportion with appropriate management across the two arms using a two-sided Z-test of proportions with pooled variances.
次要结局
- Change in management(Up to 2 years)
- Unnecessary invasive procedures(Up to 2 years)
- Time to diagnosis in patients with malignant nodules(From the time of expert provider evaluation to the time of final diagnosis in days, assessed up to 2 years)
研究者
Fabien Maldonado
Professor of Medicine
Vanderbilt-Ingram Cancer Center