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.
Accurate identification, precise dissection, and careful preservation of critical structures, such as nerves and blood vessels, are key to successful surgical outcomes. Unintended and/or unrecognized injuries to critical structures result in debilitating short- and long-term morbidity, avoidable mortality, and considerable socioeconomic and healthcare burdens. ChemImage has developed a Molecular Chemical Imaging endoscope (MCI-E) to be deployed as an intraoperative imaging device for real-time detection of key anatomical structures. MCI-E does not require the use of contrast agents, and employs visible-near infrared (vis-NIR) reflectance hyperspectral imaging. We tested the in vivo performance of MCI-E by collecting high quality vis-NIR signatures from several anatomical structures, including ureters, arteries, and veins in live pigs under general anesthesia. In this paper, we will present successful MCI-E detection of lymph node, ureter, vessels, nerve, bowel, and thyroid in background tissues under relevant in vivo conditions.
If successful, integration of MCI-E into surgical procedures will enable real-time automated detection of anatomical structures during surgeries. The benefits of this capability include the opportunity of reduced surgery time, decreased patient risk, fewer repeat surgeries, and enhancement of surgeon training.
Visualization and identification of critical structures such as blood vessels and tumor margins during surgery can often be difficult. The impact of misidentification of such structures can range from internal bleeding to inadequate excision of a malignant tumor and the subsequent need for additional surgery. We are developing an intraoperative device which will provide surgeons with the ability to visualize specified anatomic structures in real-time and without the use of labels (i.e. reagents). This imaging tool employs diffuse reflectance Molecular Chemical Imaging (MCI), a technology combining molecular spectroscopy and digital imaging for non-invasive, non-contact and reagentless evaluation of human tissues. In order to implement real-time sensing, we have developed a new approach to MCI, based on the principles of compressive sensing, and involving a novel, multivariate liquid crystal tunable filter technology. This technology can facilitate real-time detection of biological materials versus complex backgrounds with equal performance to that achieved by conventional MCI instruments. In this paper, we will present results demonstrating the capabilities and performance of a proof-of-concept intraoperative MCI surgical device.
Colorectal cancer (CRC) is the third most common cancer in men and women in the United States. Raman Molecular Imaging (RMI) is an effective technique to evaluate human tissue, cells and bodily fluids, including blood serum for disease diagnosis. ChemImage Corporation, in collaboration with clinicians, has been engaged in development of an in vitro diagnostic Raman assay focused on CRC detection. The Raman Assay for Colorectal Cancer (RACC) exploits the high specificity of Raman imaging to distinguish diseased from normal dried blood serum droplets without additional reagents. Pilot Study results from testing of hundreds of biobank patient samples have demonstrated that RACC detects CRC with high sensitivity and specificity. However, expanded clinical trials, which are ongoing, are revealing a host of important preanalytical considerations associated with sample collection, sample storage and stability, sample shipping, sample preparation and sample interferents, which impact detection performance. Results from recent clinical studies will be presented.
Access to the requested content is limited to institutions that have purchased or subscribe to SPIE eBooks.
You are receiving this notice because your organization may not have SPIE eBooks access.*
*Shibboleth/Open Athens users─please
sign in
to access your institution's subscriptions.
To obtain this item, you may purchase the complete book in print or electronic format on
SPIE.org.
INSTITUTIONAL Select your institution to access the SPIE Digital Library.
PERSONAL Sign in with your SPIE account to access your personal subscriptions or to use specific features such as save to my library, sign up for alerts, save searches, etc.