(Computer Aided Diagnosis)
Part I – Basic Information
MIAS (Medical Image Analysis System) 80j – r-1-1
- Purpose: To provide analysis and computer aided
diagnosis of MRI scans in the cranial and abdominal areas of the body.
This program can be used as a “second reader” or to aid a physician in
analysis MRI scans for the cranial and abdominal area. The software has
been calibrated through a medical study performed from 2007-2008.
Summary 20 Client Use Only. Two weeks training included with each purchase
and subscription renewal. Unlimited email support.
Part II – Program Information
about use in medical study
Establishing Accuracy of Medical Imaging Analysis Software (MIAS) in
Identifying Cancerous Growth in MRI, CT Scans and PET Scans
Approval Date: June 15, 2007
Date: June 14, 2008
1. What is done:
medical study evaluating the MIAS software was approved on June 15th,
2007. From June 15, 2007 to September 2007, research planning sessions were
held to develop a methodology for research. Based upon the research discussion,
it was decided that we would evaluate the MIAS software using cranial MRI scans
using the “3 Plance Loc” procedure. From October 2007
to January 2008, 25 of 300 images were used to calibrate the MIAS software.
From February 2008 to present, April 2008, the first and second part of the
double blind analysis of the MRI images was performed with 150 of 275 to be
completed by April 28th.
initial results of the calibration study from December 2007 are:
protocols for making a determination on “3 Plane Loc” series were evaluated.
In addition, the evaluation considered the accuracy of a single image determination
versus a series determination. The probability of significance is set at
p<=0.15, which is the naked eye misreading rate as mentioned in past
first test was a one-way anova comparing the
statistical difference between a one reading, determination and a series
determination. The one reading determination, for n=169, has an accuracy rate
of 97% (164/169) with a false positive rate of 3% (5/169) ,
and a false negative rate of 0%. The series has an accuracy rate of 70%
(21/30) with a false positive rate of 30% (9/30, two studies), and false
negative rate of 0%. When performing the one-way Anova,
there is a statistical difference between the single image determination and
a series determination at p=0.11, which is significant to p=0.15. The 70%
success rate is mathematically determinable by root of 0.70 to 15th
power which equals 0.976 or 97.6% success rate.
second test, comparing two protocols 2 and 3, there was not a significance
difference according to the null hypothesis of p=0.15. The value of p=0.58 is
not significant to the null hypothesis. But, between images, there was a
significance of p=0.07, which means that the protocols are sensitive to the
test 3, a two-way Anova was done to compare if
there was difference between the sample or the
determination method used, as the series consensus determination of protocol
3 versus the consensus protocol 2. The
analysis showed the results for both image series difference and consensus
determination were not significant as their p values were 0.50 and 0.36
respectively. In the two protocols used, they are similar to each other in
test4, a two-way Anova was done with replications
to determine if there is significance between the series id or the consensus determination versus the single MRI
determination. There is a significance between the determination method where
the p=3.8e-7, but there is not a significance between the series id where
p=0.50. What this means is that single image determination has a greater
accuracy than the consensus determination.
the single image determination, one result of the MIAS is that it is able to
separate the three positive areas, and determine correctly which is the false positive areas (2) and the true positive area
current results from the ongoing double blind analysis, n(series)=25
and n(images) = 423 are:
Wheaton Medical Study 07-010
Using the MRI “3 Plane Loc”
Summary Series Correct 1 25 Incorrect 0 Total 25 Percentage 100.00% False
Images Correct 1 414 Incorrect 9 Total 423 Percentage 97.87% False Pos 2.13%
The series accuracy is increased to
100%, n=25, and a false positive rate of 0.00%. For individual images, the
image diagnosis accuracy is 97.87%, n=423, and a false positive rate of 2.13%.
Since the initial, calibration study of December, the series diagnostic
accuracy has increased from 70% to 100%, and the individual image, diagnostic
accuracy has increased from 97.6% to 97.9% with the false positive rate reduced
from 2.40% to 2.14%.
addition, since the calibration study of December 2007, we have made the
program easier to use, and using the current DICOMM imaging program supplied
with the images, we can process 5-7 patient series per hour. When other DICOMM
imaging programs are used, the processing rate could be increased to 15-21
patients per hour based upon using a single-core computer with a 1.8 GHz
2. What is being planned:
are expecting to complete the IRB study by August 14, 2008 (Amendment for
extension is included as attachment).
The reason we are asking for this extension is so that we can prepare a
report and research paper.
3. What problems we have encountered:
main problems we encountered were in the early phases. The program was modified
to make it easier for the future oncologist or oncologist technician to use.
Once the user interface was changed, it became a three step process to analyze
a patient series.
MIAS application is exceeding our initial expectations, and we have high
confidence that it can be used as primary diagnostic tool. Also, we have
learned how to improve the program and what gained new basic research insight
into the development and detection of cancer.
FIRST RESULTS OF MEDICAL
STUDY USING MIAS 60 LABORATORY
David Kanecki, MBA, A.C.S., Bio. Sci.
Kanecki Associates, Inc., *
P.O. Box 866 * Kenosha, WI 53141 * UNITED STATES
FIRST RESULTS OF MEDICAL STUDY USING MIAS 60
David Kanecki, MBA, A.C.S., Bio. Sci.
Associates, Inc., * P.O. Box 866 * Kenosha, WI 53141 * UNITED STATES
ABSTRACT Based upon initial
testing, the MIAS 60 program could be used as a screening program for cancer,
and as an assistant for cancer determination. As a screening program, the
program has a 95.6% accuracy rate, and as a cancer determination program, it
has a 82.4% accuracy rate. In addition, there are no
false positives given as a result. This means that a patient will not be
misdiagnosed because of false positive. The screen accuracy range is
approximately 92-100%, and the cancer detection range is 65-100 percent. In
screening, the program surpasses a human reader, and in cancer detection via a
“3 Plane Loc” analysis, it is approximately equal to a human reader. *
This study was performed
at Wheaton Franciscan Hospital of Racine, WI.
INTRODUCTION The purpose of
this study is to determine the accuracy rate of the MIAS 60 program to detect
cancer in patients using a “3 Plane loc” analysis. The study consists of
analyzing 300 patient samples, and this report gives results for the first set
of 25 patient samples. The MIAS 60 Laboratory program provides an analysis
using multiple measurements and generating a single conclusion for an individual
slide and the whole series as positive or negative. The conclusion from the
whole series is what is important in determining if someone has cancer. The
first part of the testing involved calibrating the MIAS 60 Laboratory program
along with establishing patient control sets to use a reference. These control
sets were selected by the variation of the “3 Plane Loc” process and on
comparative anatomy of the scans to provide a close, accurate starting point.
Once the control sets were setup, the first experiments were done.
** MATERIALS AND METHODS The
first part of performing the medical analysis was to select a set of patients
as the reference set for the study. The selected set is references by a
notation of gender (f/m), nc
(negative control) or pc (positive control), and nc
or pc number, i.e. 1. Thus, ‘fnc1’ would indicate that the a
female, negative, control one was used for the analysis. The exam use specifies
which reference set to use, based upon the variation of the “3 place loc”
examination performed. When there is a difference between the predicted result
of cancer and the expected result of cancer, a second review is conducted. The
second review consists of comparing the patient report for the test, and
determining if the symptoms are positive or negative, relative to the two
patient samples. A positive designation is given when a patient or patients
have symptoms found in two different anatomical areas of the brain. This method
is used because all of the patient samples we are based upon the patient having
symptoms as left sided weakness, dizziness, blurred vision, etc. Thus, the
second review is used to compare conflicting results between the predicted determination by MIAS. Based upon the notation used, the
following table shows which patient data we used as control sets: Patient ID
Gender Exam Use Cancer Present Notation Name Number of MRI scans P010 F 1 P
Fpc1 21 P001 F 1 N Fnc1 15 P004 M 1 N Mnc1 15 P005 F 3 N Fnc3 21 (2 visits)
P006 F 1 N Fnc2 42 P007 F 4 N Fnc4 33 P022 M 5 N Mnc2 15 From this sample set,
a series of 25 experiments are performed. The goals of the experiments are 1)
to determine the accuracy rate of predicting cancer in a MRI test series and 2)
to determine the accuracy of recognizing significant, symptom areas that are not
The summary of the results are:
By Cancer By Symptom Total 23, 100% 23, 100% Correct
19, 82.6% 22, 95.6% False Positive 4, 17.4% 1, 4.3% False Negative 0, 0.0% 0.
0% With the cancer analysis, the program is
approximately equal to a human reader, p=0.15 error rate, and the program error
rate is p=0.164. *In addition, the program has a false positive rate 17.4%
percent which means the reading accuracy can range from 69- 100% accuracy,
exceeding a human reader at the upper levels. By having the program issue a
false positive and not issue a false negative, this means the program’s error
will not result in a missed diagnosis. With the symptoms, the program is better
than a human reader with an accuracy rate of 95.6% and an error rate of 4.4%, p=0.044,
which is better than p=0.15, our null hypothesis for a human reader. In
addition the program has a 4.4% false positive rate which means that it range of accuracy is 91.2% to 100%, which is better than the
null hypothesis of a human reader. Therefore, this shows
the MIAS can be used for screening along with a secondary review
*** CONCLUSION The results of this study show that the MIAS surpass a human
reader for screening, and is approximately equal to a human reader for cancer
determination. Since the program does not issue a false positive, the benefit
is toward better treatment because a lack of a false negative diagnosis means
that a patient is not misdiagnosed where a cancer exists. Based upon these
results, the MIAS program could be used as a screening program for cancer, and
as an assistant for diagnosing cancer. The patient samples used in this study
were supplied by Wheaton Franciscan Hospital of Racine, WI. The medical study
is being conducted at the same hospital.
MIAS, Medical Image Analysis
System, uses a two dimensional approach to spot cancer. The reason this
approach is more accurate and efficient than the three-dimensional approach
used today is due to the computers software ability for spotting the cancers
location by pixel rating as opposed to someone having to determine an area from
a visual contrast. After the individual determines which areas that the
fluorescent dyes highlight an assumption is made which runs a risk of human
error. The ability to spot the cancer by computer software pixel ratings
increases location accuracy and reduced errors in reading radiological CT, MRI,
and PET scans. Combined the two test run consistently could solve the problems
that exist in radiological diagnosis!
** The Medical Imaging Analysis
Software uses a special patented Dicomm File
Converter to extract the bipmap files used by all
Medical Scanners. Then, a pixel is assigned a value of 0 (black) – 24 MILLION
(bright white). A cancer usually is observed on a scan with a value of 150 or
over Based upon the statistical value and pixel value a cancer can be detected
to an exact location on our grid of 5000 by 5000 pixels The MIAS provides an
image of the cancer shape, location, intensity, and many other features to
detect cancer smaller than 1mm in size!
*** Imaging Enhancements have
the ability for earlier cancer detection less than 1mm sq from modifying the
pixel rating from 0-255 to 0-24 million range. This
has been done when the program applies ability while reading jpeg files or
bitmap files with 24-bit color. Currently, the program works on the 2006 Dicomm standard of a bitmap file of 8-bit grayscale and
24-bit gray scale files that is run on all machines.