SBIR-STTR Award

Decision Support System For Predicting Outcome Of Er+ Breast Cancers
Award last edited on: 1/31/12

Sponsored Program
SBIR
Awarding Agency
NIH : NIBIB
Total Award Amount
$207,067
Award Phase
1
Solicitation Topic Code
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Principal Investigator
Dave Harding

Company Information

Ibris Inc

307 Margaret Court
South Plainfield, NJ 07080
   (732) 993-4208
   N/A
   www.ibrisinc.com
Location: Single
Congr. District: 06
County: Middlesx

Phase I

Contract Number: 1R43EB015199-01
Start Date: 9/7/11    Completed: 8/31/12
Phase I year
2011
Phase I Amount
$207,067
We propose an alternative, inexpensive means for identifying the subset of women with ER+ breast cancer for whom hormonal therapy alone is sufficient, and adjuvant chemotherapy is not required. Our novel approach uses computer vision and machine learning techniques to extract information from digitized histological sections of breast tissue (e.g. graphical and morphological arrangement of nuclei, lymphocytes, textural appearance, and tubule density), yielding a continuous image-based risk score (IbRiS) from zero to one that predicts the risk of recurrence. By choosing the appropriate cutoff value, IbRiS can be used to stratify ER+ patients into two classes: low and high risk. A low risk identifies those women who would respond well to hormonal therapy alone. Of the 120,000 women annually diagnosed with estrogen receptor positive (ER+) breast cancer in the US, the vast majority will be considered at high risk of having distant recurrence (metastasis) within 10 years. Under current National Comprehensive Cancer Network (NCCN) guidelines, these women will be advised to receive adjuvant chemotherapy in addition to standard hormonal treatment (e.g. tamoxifen). However, 85% of these women will not benefit from chemotherapy, and yet will still incur its deleterious side-effects. The only non-investigational tool to help better determine which women should receive tamoxifen alone is the Oncotype Dx molecular assay, which is now widely used by medical oncologists. Oncotype Dx is able to correctly reclassify (as low-risk) 50% of those women with ER+ cancers that have been classified as high-risk (or intermediate-risk) by the NCCN guidelines, obviating their need for chemotherapy. However, Oncotype Dx is inaccessible to the majority of women in the US (and worldwide) because of its high cost ($4500), and requirement that the tissue samples be sent to specialized remote facilities. Consequently, there is clearly a market need for a lower-priced assay capable of reaching a wider audience. The specific aims of this proposal are as follows: 1) develop an image-based risk score (IbRiS) for predicting the subset of women with ER+ breast cancer that wil respond wel without chemotherapy and 2) evaluate IbRiS performance in predicting recurrence over an independent set of ER+ breast cancers treated with tamoxifen alone. IbRiS has several key advantages over molecular assays. First, it requires no disruption of the current clinical protocol since the necessary tissue samples are already collected during routine pathological examinations. Second, IbRiS has a zero cost-of-goods sold, and thus could serve as either a lower-priced alternative to a molecular assay or as a quantitative triage, determining which patients should be administered the more expensive molecular test. Finally, since IbRiS only requires a digital slide scanner (i.e. no specialized facility is necessary), its footprint could extend worldwide (via the internet).

Public Health Relevance:
Every year tens of thousands of women in the US with estrogen receptor positive (ER+) breast cancer are treated with chemotherapy, though only a few thousand will benefit from it. In this proposal we will develop an image-based risk score (IbRiS) to predict which women with ER+ breast cancer do not require chemotherapy. This test will provide an economical alternative to the far more expensive gene-expression based assays currently in use.

Thesaurus Terms:
(Z)-2-[4(1,2-Diphenyl-1-Butenyl)-Phenoxyl]-N,N-Dimethylethanamine;1-P-Beta-Dimethylamino-Ethoxyphenyl-Trans-1,2-Diphenylbut-1-Ene;Adjuvant Chemotherapy;Adjuvant Drug Therapy;Adverse Effects;Africa;Algorithms;Appearance;Assay;Bioassay;Biologic Assays;Biological Assay;Biopsy Sample;Biopsy Specimen;Breast;Breast Cancer;Breast Tissue;Cancers;Cell Nucleus;China;Clinical Protocols;Cognitive Disturbance;Cognitive Impairment;Cognitive Decline;Cognitive Function Abnormal;Computer Vision Systems;Computer-Assisted Image Analyses;Computer-Assisted Image Analysis;Country;Data;Data Set;Dataset;Decision Support Systems;Dentistry;Detection;Development;Diagnosis;Distant;Disturbance In Cognition;Endocrine Therapy;Estrogen Receptor Positive;Ethanamine, 2-(4-(1,2-Diphenyl-1-Butenyl)Phenoxy)-N,N-Dimethyl-, (Z)-;Europe;Evaluation;Event;Exhibits;Flr;Failure (Biologic Function);Gene Expression;Genomics;Gland;Graph;Guidelines;H And E;Hair;Health;Hematoxylin And Eosin;Hematoxylin And Eosin Staining Method;Histologic;Histologically;Histopathology;Hormonal;Hormonal Therapy;Image;Image Analyses;Image Analysis;Impaired Cognition;India;Infrastructure;Internet;Investigators;Loinc Axis 4 System;Label;Life;Lymphocyte;Lymphocytic;Machine Learning;Mainland China;Malignant Neoplasms;Malignant Tumor;Mammary Gland Parenchyma;Mammary Gland Tissue;Marketing;Measures;Medical Oncologist;Medicine;Metastasis;Metastasize;Metastatic Neoplasm;Metastatic Tumor;Molecular;Nccn;National Comprehensive Cancer Network;Nausea;Neoplasm Metastasis;Nuclear;Nucleus;Outcome;Ovarian;Patients;Pennsylvania;Performance;Phase I Study;Price;Recurrence;Recurrent;Research Infrastructure;Research Personnel;Research Specimen;Researchers;Resolution;Risk;Secondary Neoplasm;Secondary Tumor;Slide;Spatial Distribution;Specimen;Staging;Staining Method;Stainings;Stains;Structure;System;Tamoxifen;Techniques;Testing;Tissue Sample;Toxic Effect;Toxicities;Treatment Side Effects;Triage;Tumor Cell Migration;Universities;Www;Woman;Base;Cancer Metastasis;Chemotherapy;Cognitive Dysfunction;Cognitive Loss;Cognitively Impaired;Computer Vision;Content Based Retrieval;Cost;Density;Developmental;Digital;Failure;Feature Detection;Feature Recognition;High Risk;Hormone Therapy;Image Evaluation;Imaging;Imaging Segmentation;Kernel Methods;Lymph Cell;Malignancy;Malignant Breast Neoplasm;Malignant Breast Tumor;Neoplasm/Cancer;New Approaches;Novel Approaches;Novel Strategies;Novel Strategy;Phase 1 Study;Pricing;Prognostic;Side Effect;Statistical Learning;Support Vector Machine;Therapy Adverse Effect;Tool;Treatment Adverse Effect;Tumor Cell Metastasis;Web;World Wide Web

Phase II

Contract Number: ----------
Start Date: 00/00/00    Completed: 00/00/00
Phase II year
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Phase II Amount
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