# Presentation: 933707

## Clinical Description – Part I
William Sacks, PhD, MD

**William Sacks, PhD, MD**

**COMPUTERIZED THERMAL IMAGING, INC****.**
** *****Breast Cancer System         BCS 2100******                  *****P010035**** **** **
**Radiological Devices Advisory Panel**
**December 10, 2002**

- Sacks - Clinical Description

- 12/10/02

##  A new type of thermographic device
 Adjunct to mammography
 Renders +/- (based on IOS* score)
 Intended for women on their
     way to biopsy only
 Intended for mammographic 
     masses only 
 Intended to save biopsies
    of LTOBs**
__________________________________________________________________________
  *  Index of Suspicion 
  ** Lesions that Turn Out to be Benign 

** **_**Adjunct**_** to mammography**
** ****Renders **_**+/-**_** (based on IOS* score)**
** ****Intended for **_**women on their**_
**     **_**way to biopsy**_** only**
** ****Intended for **_**mammographic**_** **
**     **_**masses**_** only **
** ****Intended to **_**save biopsies**_
**    ****of LTOBs****
**__________________________________________________________________________**
**  *****  Index of Suspicion **
**  ****** Lesions that Turn Out to be Benign **

- Sacks - Clinical Description

- 12/10/02

## POINTS TO BE COVERED

 What BCS 2100 (BCS) is and
     is not intended to do
 How BCS does it
 What the clinical trial
     demonstrated
 Labeling issues

** ****What BCS 2100 (BCS) is and**
**     ****is not intended to do**
** ****How BCS does it**
** ****What the clinical trial**
**     ****demonstrated**
** ****Labeling issues**

- Sacks - Clinical Description

- 12/10/02

## POINTS TO BE COVERED

 What BCS 2100 (BCS) is and
     is not intended to do
 How BCS does it
 What the clinical trial
     demonstrated
 Labeling issues

** ****What BCS 2100 (BCS) is and**
**     ****is not **_**intended**_** to do**
** ****How BCS does it**
** ****What the clinical trial**
**     ****demonstrated**
** ****Labeling issues**

- Sacks - Clinical Description

- 12/10/02

## Historically,
conventional thermography
had a sensitivity and
specificity too low
either to replace
screening mammography or
to be a complementary
screening test. 

**conventional thermography**
**had a **_**sensitivity**_** and**
_**specificity**_** too low**
**either to **_**replace**_
**screening mammography or**
**to be a **_**complementary**_
_**screening test**_**. **

- Sacks - Clinical Description

- 12/10/02

## BCS 2100 (BCS) is a new type of thermographic device for breast cancer:
 Uses new application of
   technology
 Targets different group
   of women  

** ****Uses **_**new application**_** of**
**   ****technology**
** ****Targets **_**different group**_
**   ****of women  **

- Sacks - Clinical Description

- 12/10/02

## New application of technology involves cooling the breast to enhance the intrinsic temperature contrast between benign and malignant tissue. 

- Sacks - Clinical Description

- 12/10/02

## Different group of women targeted — not all women screened but rather only those whose screening tests (mammography and/or palpation), along with other factors, indicate need for biopsy.

- Sacks - Clinical Description

- 12/10/02

## So BCS intended not as a screening device (i.e., neither replacement nor complement to screening mammography)...

- Sacks - Clinical Description

- 12/10/02

## ...but rather as an adjunct — in particular, an adjunct to mammography: only for women on their way to biopsy (and only for those with mammographic masses).

- Sacks - Clinical Description

- 12/10/02

## Complementary vs Adjunctive

A test that is complementary to
a screening test is used on all
persons screened, i.e., it is
itself a screening test, and
therefore its results may by
themselves determine the next
step in clinical management.

**A test that is **_**complementary**_** to**
**a screening test is used on **_**all**_
**persons screened, i.e., it is**
**itself a **_**screening**_** test, and**
**therefore its results may by**
**themselves determine the next**
**step in clinical management****.**

- Sacks - Clinical Description

- 12/10/02

## Complementary vs Adjunctive
(cont.)

Complementary screening
tests therefore are on an
equal footing with each
other (e.g., mammography
and clinical examination).

**(cont.)**
_**Complementary**_** screening**
**tests therefore are on an**
_**equal**_** footing with each**
**other (e.g., mammography**
**and clinical examination).**

- Sacks - Clinical Description

- 12/10/02

##   Complementary vs Adjunctive
(cont.)

 Adjuncts, on the other
 hand, are subordinate
 to the index screening
 test, insofar as either...

**(cont.)**
** **_**Adjuncts**_**, on the other**
** ****hand, are **_**subordinate**_
** ****to the index screening**
** ****test, insofar as either...**

- Sacks - Clinical Description

- 12/10/02

##  Complementary vs Adjunctive 					(cont.) 

 they are not used on all
    persons screened (e.g., the
    BCS2100, ultrasound of solid breast
    masses, extra mammographic views,
    and biopsy itself), or
 their results do not by
    themselves determine the next
    step in clinical management (e.g.,
    mammography CAD), or 
 both (e.g., electrical impedance imaging)

** ****they are not used on all**
**    ****persons screened (e.g., the**
**    ****BCS2100, ultrasound of solid breast**
**    ****masses, extra mammographic views,**
**    ****and biopsy itself), or**
** ****their results do not by**
**    ****themselves determine the next**
**    ****step in clinical management (e.g.,**
**    ****mammography CAD), or **
** ****both (e.g., electrical impedance imaging)**

- Sacks - Clinical Description

- 12/10/02

## Intended use of BCS is to confirm the need for biopsy or change a woman’s clinical management...

- Sacks - Clinical Description

- 12/10/02

## 
...from biopsy to short-term follow-up...

**...from **_**biopsy**_** to **_**short-term follow-up**_**...**

- Sacks - Clinical Description

- 12/10/02

## ...and thereby, in its intended use, BCS can only decrease the number of biopsies,... 

- Sacks - Clinical Description

- 12/10/02

## ...i.e., can only increase specificity.

- Sacks - Clinical Description

- 12/10/02

## Intended use of BCS cannot increase detection of cancers, i.e., cannot increase sensitivity.

- Sacks - Clinical Description

- 12/10/02

## An advantage of the particular
selection of target population
(i.e., only women on their way
to biopsy) is that device false
positives* can have 
no impact on clinical
management.

* device false positive = BCS(+) result
   for a mass that is benign.

**selection of target population**
**(i.e., only women on their way**
**to biopsy) is that device false**
**positives* can have **
_**no impact on clinical**_
_**management**_**.**
*** device false positive = BCS(+) result**
**   ****for a mass that is benign.**
**  **
** **
**  **

- Sacks - Clinical Description

- 12/10/02

## But is there a concern
over the potential
psychological impact of a
positive mammogram, followed
by a false positive BCS
result, i.e., on a woman who
does not, in fact, have
cancer?

**over the potential**
_**psychological**_** impact of a**
**positive mammogram, followed**
**by a false positive BCS**
**result, i.e., on a woman who**
**does not, in fact, have**
**cancer?**
**  **

- Sacks - Clinical Description

- 12/10/02

## Is BCS an alternative to biopsy?  

In 80 to 85% of women who obtain the BCS test it will end up being in addition to biopsy; only 15 to 20% of such women will end up not getting a biopsy in addition, at least not immediately.

**In 80 to 85% of women who obtain the BCS test it will end up being **_**in addition to**_** biopsy; only 15 to 20% of such women will end up not getting a biopsy in addition, at least not immediately.**

- Sacks - Clinical Description

- 12/10/02

## POINTS TO BE COVERED

 What BCS 2100 (BCS) is and
     is not intended to do
 How BCS does it
 What the clinical trial
     demonstrated
 Labeling issues

** ****What BCS 2100 (BCS) is and**
**     ****is not intended to do**
** ****How BCS does it**
** ****What the clinical trial**
**     ****demonstrated**
** ****Labeling issues**

- Sacks - Clinical Description

- 12/10/02

## BCS calculates an IOS* score for the ROI** selected by the radiologist, who bases this selection on the mammographic location of the mass.

*  IOS = Index of Suspicion
** ROI = Region of Interest

***  IOS = Index of Suspicion**
**** ROI = Region of Interest**
**        **

- Sacks - Clinical Description

- 12/10/02

## BCS then compares IOS with the predetermined threshold 20.59, and if...

**        **

- Sacks - Clinical Description

- 12/10/02

## IOS score below
threshold  => (-)result
=> change biopsy to
short-term follow-
up (similar to BIRADS 3) 

**threshold  => (-)result**
**=> ****change ****biopsy to**
_**short-term**_** **_**follow-**_
_**up**_** ****(similar to BIRADS 3) **
**        **

- Sacks - Clinical Description

- 12/10/02

## IOS score at or above
threshold  => (+) result
=> continue with plan
to biopsy

**threshold  => (+) result**
**=> ****continue with plan**
**to ****biopsy**

- Sacks - Clinical Description

- 12/10/02

## Side effect: 
Some cancer diagnoses may be delayed (false negatives). 

**Some cancer diagnoses may be delayed ****(false negatives)****.**** **

- Sacks - Clinical Description

- 12/10/02