SBIR-STTR Award

This proposal is for the development of a fiber-optic based system for the detection and surveillance of early stage bladder cancer. The technology is based on Polarized Elastic Scattering Spectroscopy (PESS). Over 500,000 people in the US are afflicted with bladder cancer. Detection currently depends on visual examination by white light cystoscopy. This is generally performed when a patient presents with symptoms like hematuria or abnormal cells in the urine. This is followed by biopsy and surgical intervention. The recurrence rate for bladder cancer after surgery is an onerous 50-70%. This results in multiple repeat endoscopies and surgeries, with continued discomfort and stress to the patient. Bladder cancer is also the most expensive cancer, with an annual estimated cost in the US of $4B and a lifetime treatment cost for each surgical patient in the range of $100-200K. Early detection before the cancer reaches an invasive stage is often critical to long-term prognosis. The primary goals of this proposal are to determine the feasibility of using PESS for detecting early stage bladder cancer and developing PESS into a tool for optically guided interventions as well as a routine endoscopic screening tool for the doctor's office. Co-registration of a biopsy site with the site of spectroscopic measurement has been a consistent problem with optically and image-guided endoscopic and surgical interventions. To address this problem, a tool will be developed during this Phase 1 program that integrates a PESS fiber-optic probe with commercially-available biopsy forceps to ensure accurate correlation of histopathology with spectroscopic data. This optically-guided biopsy tool will be used in a 30-patient preliminary clinical study to acquire PESS spectra and histopathological assessments of samples biopsied from the same site. These data will be used to determine preliminary correlation between PESS spectral features and tissue histology for empirical classification of PESS spectra as indicative of normal urothelium, interstitial cystitis, low-grade bladder carcinoma, or high-grade bladder carcinoma. A successful Phase 1 outcome will lead to a broader multi-center Phase II clinical study, refined algorithms for tissue classification, and commercialization of the integrated optically-guided biopsy forceps. PESS has the potential to differentiate between normal and diseased tissues with sensitivity and specificity >90% using no indicator dyes, molecular markers, or other exogenous agents. Compared to imaging modalities such as NMR, CT and ultrasound, optically-guided PESS technology is simple, low cost, and easy to use with minimal training. PESS' ability to quickly detect lesions with high sensitivity and specificity can lead to fewer unnecessary tissue biopsies, earlier detection of recurrence, and reduced need for post-operative cystoscopic examinations, while reducing the cost of health care and improving patient outcomes and quality of life. OTI, with deep experience in optically- guided technology development, along with a world-class team of collaborators including Boston University, the Fraunhofer Institute, and Cook Urological, Inc. is uniquely equipped to successfully complete this program. 7.

Public Health Relevance:
Bladder cancer is the fifth most commonly diagnosed malignancy in the United States, and its high recurrence rate requires frequent post-operative visits for cystoscopic examination and surgery when new cancers are observed. Current clinical methods and practice are directed at surgically removing tumors identified visually or from biopsy of visually `suspicious' areas. If successful, the outcome of this grant will be a method of detecting bladder cancer before it is visible, allowing for earlier detection and treatment with fewer unnecessary tissue biopsies, a reduction in the need for post-operative follow-up and intervention, while reducing the cost of health care and improving patient outcomes and quality of life.

Public Health Relevance:
This Public Health Relevance is not available.

Thesaurus Terms:
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This proposal is for the development of a fiber-optic based system for the detection and surveillance of early stage bladder cancer. The technology is based on Polarized Elastic Scattering Spectroscopy (PESS). Over 500,000 people in the US are afflicted with bladder cancer. Detection currently depends on visual examination by white light cystoscopy. This is generally performed when a patient presents with symptoms like hematuria or abnormal cells in the urine. This is followed by biopsy and surgical intervention. The recurrence rate for bladder cancer after surgery is an onerous 50-70%. This results in multiple repeat endoscopies and surgeries, with continued discomfort and stress to the patient. Bladder cancer is also the most expensive cancer, with an annual estimated cost in the US of $4B and a lifetime treatment cost for each surgical patient in the range of $100-200K. Early detection before the cancer reaches an invasive stage is often critical to long-term prognosis. The primary goals of this proposal are to determine the feasibility of using PESS for detecting early stage bladder cancer and developing PESS into a tool for optically guided interventions as well as a routine endoscopic screening tool for the doctor's office. Co-registration of a biopsy site with the site of spectroscopic measurement has been a consistent problem with optically and image-guided endoscopic and surgical interventions. To address this problem, a tool will be developed during this Phase 1 program that integrates a PESS fiber-optic probe with commercially-available biopsy forceps to ensure accurate correlation of histopathology with spectroscopic data. This optically-guided biopsy tool will be used in a 30-patient preliminary clinical study to acquire PESS spectra and histopathological assessments of samples biopsied from the same site. These data will be used to determine preliminary correlation between PESS spectral features and tissue histology for empirical classification of PESS spectra as indicative of normal urothelium, interstitial cystitis, low-grade bladder carcinoma, or high-grade bladder carcinoma. A successful Phase 1 outcome will lead to a broader multi-center Phase II clinical study, refined algorithms for tissue classification, and commercialization of the integrated optically-guided biopsy forceps. PESS has the potential to differentiate between normal and diseased tissues with sensitivity and specificity >90% using no indicator dyes, molecular markers, or other exogenous agents. Compared to imaging modalities such as NMR, CT and ultrasound, optically-guided PESS technology is simple, low cost, and easy to use with minimal training. PESS' ability to quickly detect lesions with high sensitivity and specificity can lead to fewer unnecessary tissue biopsies, earlier detection of recurrence, and reduced need for post-operative cystoscopic examinations, while reducing the cost of health care and improving patient outcomes and quality of life. OTI, with deep experience in optically- guided technology development, along with a world-class team of collaborators including Boston University, the Fraunhofer Institute, and Cook Urological, Inc. is uniquely equipped to successfully complete this program. 7.

Public Health Relevance:
Bladder cancer is the fifth most commonly diagnosed malignancy in the United States, and its high recurrence rate requires frequent post-operative visits for cystoscopic examination and surgery when new cancers are observed. Current clinical methods and practice are directed at surgically removing tumors identified visually or from biopsy of visually `suspicious' areas. If successful, the outcome of this grant will be a method of detecting bladder cancer before it is visible, allowing for earlier detection and treatment with fewer unnecessary tissue biopsies, a reduction in the need for post-operative follow-up and intervention, while reducing the cost of health care and improving patient outcomes and quality of life.

Project Terms:
21+ years old; Abnormal Cell; Abscission; Achievement; Achievement Attainment; Active Follow-up; Address; Adult; Algorithms; Analysis, Data; Area; Atlas of Cancer Mortality in the United States; Au element; Biopsy; Biopsy Sample; Biopsy Specimen; Bladder; Bladder Tissue; Body Tissues; Boston; Cancer Detection; Cancer Maps; Cancer Treatment; Cancer of Bladder; Cancer of Urinary Bladder; Cancerous; Cancers; Carcinoma; Carcinoma of bladder; Carcinoma of the Urinary Bladder; Catheters; Cessation of life; City of Boston; Classification; Clinical; Clinical Evaluation; Clinical Research; Clinical Study; Clinical Testing; Collaborations; Coloring Agents; Computer Programs; Computer software; Consent Documents; Consent Forms; Cystoscopes; Cystoscopy; Data; Data Analyses; Data Set; Dataset; Death; Detection; Development; Devices; Diagnosis; Diagnosis, Ultrasound; Diagnostic; Doctor of Philosophy; Dyes; Early Diagnosis; Echography; Echotomography; Elastic scattering spectroscopy; Electronics; Endoscopy; Ensure; Epithelial Neoplasms, Malignant; Epithelial Tumors, Malignant; Ethics Committees, Research; Excision; Excision biopsy; Excisional Biopsy; Extirpation; Face; Feasibility Studies; Fiber Optics; Forcep; Forecast of outcome; Goals; Gold; Grant; Graphical interface; Health Care Costs; Health Costs; Healthcare Costs; Hematuria; Histology; Histopathology; Human, Adult; IRBs; Image; Informed Consent Documents; Informed Consent Forms; Institutes; Institutional Review Boards; Interstitial Cystitis; Intervention; Intervention Strategies; Jaw; Lead; Lesion; Light; Malignant; Malignant - descriptor; Malignant Bladder Neoplasm; Malignant Neoplasm Therapy; Malignant Neoplasm Treatment; Malignant Neoplasms; Malignant Tumor; Malignant Tumor of the Bladder; Malignant neoplasm of urinary bladder; Measurement; Medical Imaging, Ultrasound; Methods; Monitor; Multi-Institutional Clinical Trial; Multi-center clinical study; Multi-center clinical trial; Multi-site clinical study; Multi-site clinical trial; Normal Tissue; Normal tissue morphology; Operation; Operative Procedures; Operative Surgical Procedures; Optical Biopsy; Optics; Outcome; Outcome Measure; Patients; Pb element; Ph.D.; PhD; Phase; Photoradiation; Physicians' Offices; Post-Operative; Postoperative; Postoperative Period; Predictive Value; Procedures; Prognosis; Programs (PT); Programs [Publication Type]; QOL; Quality of life; Recurrence; Recurrent; Removal; Research; Research Ethics Committees; SCHED; Schedule; Screening procedure; Sensitivity and Specificity; Site; Software; Spectroscopy; Spectrum Analyses; Spectrum Analysis; Staging; Stress; Surgical; Surgical Interventions; Surgical Procedure; Surgical Removal; Symptoms; System; System, LOINC Axis 4; Systematics; Technology; Testing; TimeLine; Tissues; Training; Treatment Cost; Ultrasonic Imaging; Ultrasonogram; Ultrasonography; Ultrasound Test; Ultrasound, Medical; United States; Universities; Urinary Bladder Malignant Tumor; Urinary System, Bladder; Urinary System, Urine; Urine; Urology; Urothelium; Visit; Visual; Work; abstracting; adult human (21+); analytical tool; anticancer therapy; base; bladder Carcinoma; cancer diagnosis; cancer therapy; clinical test; commercialization; computer program/software; cooking; cost; design; designing; diagnosis standard; diagnostic ultrasound; early detection; efficacy testing; epithelial carcinoma; experience; facial; follow-up; graphic user interface; graphical user interface; heavy metal Pb; heavy metal lead; imaging; imaging modality; improved; in vivo; instrument; interventional strategy; malignancy; manufacturing process; miniaturize; minimally invasive; molecular marker; multi center clinical study; multi center clinical trial; multi site clinical study; multi site clinical trial; neoplasm/cancer; novel; outcome forecast; patient population; primary outcome; programs; prospective; prototype; public health relevance; research clinical testing; resection; response; screening; screenings; sonogram; sonography; sound measurement; surgery; technology development; tool; tumor; ultrasound; ultrasound imaging; ultrasound scanning; urinary bladder; urologic; urological