Significance: Peripheral pitting edema is a clinician-administered measure for grading edema. Peripheral edema is graded 0, 1 + , 2 + , 3 + , or 4 + , but subjectivity is a major limitation of this technique. A pilot clinical study for short-wave infrared (SWIR) molecular chemical imaging (MCI) effectiveness as an objective, non-contact quantitative peripheral edema measure is underway.
Aim: We explore if SWIR MCI can differentiate populations with and without peripheral edema. Further, we evaluate the technology for correctly stratifying subjects with peripheral edema.
Approach: SWIR MCI of shins from healthy subjects and heart failure (HF) patients was performed. Partial least squares discriminant analysis (PLS-DA) was used to discriminate the two populations. PLS regression (PLSR) was applied to assess the ability of MCI to grade edema.
Results: Average spectra from edema exhibited higher water absorption than non-edema spectra. SWIR MCI differentiated healthy volunteers from a population representing all pitting edema grades with 97.1% accuracy (N = 103 shins). Additionally, SWIR MCI correctly classified shin pitting edema levels in patients with 81.6% accuracy.
Conclusions: Our study successfully achieved the two primary endpoints. Application of SWIR MCI to monitor patients while actively receiving HF treatment is necessary to validate SWIR MCI as an HF monitoring technology.
Heart failure (HF) has a significant impact on patient outcomes and health care costs. Objective monitoring of pitting edema level of a HF patient may help clinicians reduce the volume of patient re-admissions. To address this, ChemImage is developing a Molecular Chemical Imaging (MCI) device for noninvasive measurement of peripheral edema level in HF patients. In an initial clinical study, edema grade was predicted in HF patients with 86% accuracy. Results from a follow-up clinical trial demonstrating the capability of MCI to monitor changes in a HF patient’s peripheral edema over time during the course of treatment will be presented.
Heart failure (HF) has a large impact on patient outcomes and health care costs. Objective monitoring of the pitting edema level of a HF patient may help clinicians reduce the amount of readmissions. ChemImage is developing a Molecular Chemical Imaging (MCI) device for monitoring HF patients that will non-invasively quantify peripheral edema. Results from a completed in-human clinical trial will be presented demonstrating ability to discriminate between healthy volunteers and HF patients with all levels of pitting edema and correct prediction of peripheral edema grade across the patient population. Follow-on clinical trials will address monitoring patients during treatment.
Significance: A key risk faced by oncological surgeons continues to be complete removal of tumor. Currently, there is no intraoperative imaging device to detect kidney tumors during excision.
Aim: We are evaluating molecular chemical imaging (MCI) as a technology for real-time tumor detection and margin assessment during tumor removal surgeries.
Approach: In exploratory studies, we evaluate visible near infrared (Vis-NIR) MCI for differentiating tumor from adjacent tissue in ex vivo human kidney specimens, and in anaesthetized mice with breast or lung tumor xenografts. Differentiation of tumor from nontumor tissues is made possible with diffuse reflectance spectroscopic signatures and hyperspectral imaging technology. Tumor detection is achieved by score image generation to localize the tumor, followed by application of computer vision algorithms to define tumor border.
Results: Performance of a partial least squares discriminant analysis (PLS-DA) model for kidney tumor in a 22-patient study is 0.96 for area under the receiver operating characteristic curve. A PLS-DA model for in vivo breast and lung tumor xenografts performs with 100% sensitivity, 83% specificity, and 89% accuracy.
Conclusion: Detection of cancer in surgically resected human kidney tissues is demonstrated ex vivo with Vis-NIR MCI, and in vivo on mice with breast or lung xenografts.
Heart failure (HF) occurs when the heart is unable to pump enough blood to meet blood and oxygen requirements and is among the most common causes for hospitalization in the United States. A retrospective analysis determined that 22% of HF patients are readmitted within 30 days of release from the hospital, and the costs for readmission are substantial. Measuring the severity of peripheral edema is one method for monitoring the treatment of a HF patient. Pitting peripheral edema is a subjective measure administered by clinicians who create an indentation mid-tibia and observe depth and time to resolve the indentation. The results are graded 0, 1, 2, 3 or 4, and this information is used in the patient treatment plan. ChemImage is engaged in a clinical study to determine whether Molecular Chemical Imaging (MCI) in the short wave infrared (SWIR) spectral region can provide an objective measure of peripheral edema in HF patients. In this paper, the performance of SWIR MCI for discriminating between healthy volunteers and HF patients with high grade pitting edema will be presented. This technology may provide a non-invasive methodology for quantitative peripheral edema measurement. As the technology matures, it is envisioned patient self-monitoring, with wireless transmission of edema levels while at home, can aid clinicians in monitoring HF patients for necessary treatment changes remotely, to improve patient outcomes, and ultimately, reduce HF hospital readmission rates.
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