1. No category

HOW TO IMPROVE QWBRLG STRATEGY FOR THE FUTURE ?
ANABAS
 : A ROUTINE TOOL FOR AN ACCURATE, RELIABLE
AND REPRODUCIBLE ASSESSMENT IN QUANTITATIVE WHOLE
BODY AUTARADIOGRAPHY.
P. Dupont1, W. Maio1, Y. Collenot2 and Jo. Simiand1
1 Sanofi~Synthelabo
Recherche, 195 route d'Espagne, F-31036, Toulouse cedex
2 Sanofi~Synthelabo Recherche, 371 rue du Professeur J. Blayac, F-34481,
Montpellier cedex 04
4 – 5 February, GMP meeting, Paris
How to improve QWBRLG strategy for the future ?
AnaBas
 : A routine tool for an accurate, reliable and reproducible
assessment in Quantitative Whole Body Autoradiography.
Introduction
• Previous presentations of the development of an image registration software
has been done during the US WBA meetings in St Louis in 1998, in New
Orleans in 2001, in London in April 2002 and in Orlando in April 2003.
Basic statements are:
• Quantitative data for tissue distribution studies are obtained from computer
assisted methods (mainly RLG and DNA) and these data have been well
correlated with data issued from LSC,
• It is sometimes difficult and even not possible to assess, with these
computer assisted methods, to quantitative measurements in tissues or
organs (especially when low RT levels occurred in long term sampling times),
• There is no available method based on the determination of outlines of ROI
directly issued from tissue localization on the image of the specimen (section)
and not from the distribution of RT on the image of the autoradiogram.
4 – 5 February, GMP meeting, Paris
How to improve QWBRLG strategy for the future ?
AnaBas
 : A routine tool for an accurate, reliable and reproducible
assessment in Quantitative Whole Body Autoradiography.
Actual situation
4 – 5 February, GMP meeting, Paris
How to improve QWBRLG strategy for the future ?
AnaBas
 : A routine tool for an accurate, reliable and reproducible
assessment in Quantitative Whole Body Autoradiography.
Actual situation
No
Nam e
Area [mm ²] PSL/m m²
1
Liver
24.38
24.53
2
Liver
26.17
28.87
3
Liver
33.03
24.19
4
Liver
30.77
25.72
5
Adrenal
7.59
6.05
6
Kidney
132.54
10.27
7
Testis
128.94
1.10
8 Bladder content
13.42
14.49
4 – 5 February, GMP meeting, Paris
No
Name
Area [m m²] PSL/m m²
9
Lung
44.31
9.30
10
Blood
35.15
1.79
11 Cerebelum
25.07
0.62
12
Brain
71.46
0.56
13 Spinal cord
12.07
0.71
14 Myocardium
42.15
4.96
15
Parotide
9.87
11.97
16 Subm axilar gl
33.18
5.06
17
Bkg
33.23
0.43
How to improve QWBRLG strategy for the future ?
AnaBas
 : A routine tool for an accurate, reliable and reproducible
assessment in Quantitative Whole Body Autoradiography.
Actual situation (Cont’d)
No
1
2
3
4 – 5 February, GMP meeting, Paris
Name
Liver
Uveal tract
Bkg
Area [mm²] PSL/mm²
584.06
1.31
2.51
5.38
33.23
0.43
How to improve QWBRLG strategy for the future ?
AnaBas
 : A routine tool for an accurate, reliable and reproducible
assessment in Quantitative Whole Body Autoradiography.
Actual situation (Cont’d)
4 – 5 February, GMP meeting, Paris
How to improve QWBRLG strategy for the future ?
AnaBas
 : A routine tool for an accurate, reliable and reproducible
assessment in Quantitative Whole Body Autoradiography.
MPK requirements
Create a new application
• Under a real image analysis environment dedicated to image registration
and to quantification,
• Independent of the platforms and of the owner file formats,
• In a GLP environment integrating 21CFR part 11 recommendation from
FDA (users access security, data tracking, audit trail, …).
4 – 5 February, GMP meeting, Paris
How to improve QWBRLG strategy for the future ?
AnaBas
 : A routine tool for an accurate, reliable and reproducible
assessment in Quantitative Whole Body Autoradiography.
AnaBas development
• Based on use of the image analysis tools extracted from Visilog (Noesis,
Les Ulis, France),
• Use of C++ for interfaces and scripts and Visual C for registration algorithm,
• The algorithm of registration is based on extraction of a pattern (4 corner cross
markers) in a bounding box of 200 × 200 pixels from the image of the section and
correlation to the corresponding pattern on the autoradiogram,
• The algorithm of quantification is based on the inverse equation of transformation
of PSL/mm2 into OD from Tina software (sources given by Raytest,
Straubenhardt, Germany).
4 – 5 February, GMP meeting, Paris
How to improve QWBRLG strategy for the future ?
AnaBas
 : A routine tool for an accurate, reliable and reproducible
assessment in Quantitative Whole Body Autoradiography.
Previous steps before using AnaBas
• Drawing cross markers with radioactive ink at each corner of the section
during identification,
• Acquisition of the image of the autoradiogram from BAS/FLA systems
(Fuji format) or any else RLG system, or from DNC (β
β or µ Imager systems),
• Calibration (blood standard scale, IS or ES) using Tina/AIDA or dedicated
softwares in order to assess to slope and to Bkg values for LOQ determination,
• Cut of autoradiogram (at a predefined size) and save as non compressed TIFF
files (16 bits coded) or im5 (Visilog format) to avoid loss of information,
• Acquisition of the digital image of the anatomical section, in a "one to one" ratio
to prevent image distortion during registration, using a common color flat scanner
and save in JPEG format or other, as function of the resolution needed.
4 – 5 February, GMP meeting, Paris
How to improve QWBRLG strategy for the future ?
AnaBas
 : A routine tool for an accurate, reliable and reproducible
assessment in Quantitative Whole Body Autoradiography.
4 – 5 February, GMP meeting, Paris
How to improve QWBRLG strategy for the future ?
AnaBas
 : A routine tool for an accurate, reliable and reproducible
assessment in Quantitative Whole Body Autoradiography.
4 – 5 February, GMP meeting, Paris
How to improve QWBRLG strategy for the future ?
AnaBas
 : A routine tool for an accurate, reliable and reproducible
assessment in Quantitative Whole Body Autoradiography.
4 – 5 February, GMP meeting, Paris
How to improve QWBRLG strategy for the future ?
AnaBas
 : A routine tool for an accurate, reliable and reproducible
assessment in Quantitative Whole Body Autoradiography.
4 – 5 February, GMP meeting, Paris
How to improve QWBRLG strategy for the future ?
AnaBas
 : A routine tool for an accurate, reliable and reproducible
assessment in Quantitative Whole Body Autoradiography.
4 – 5 February, GMP meeting, Paris
How to improve QWBRLG strategy for the future ?
AnaBas
 : A routine tool for an accurate, reliable and reproducible
assessment in Quantitative Whole Body Autoradiography.
4 – 5 February, GMP meeting, Paris
How to improve QWBRLG strategy for the future ?
AnaBas
 : A routine tool for an accurate, reliable and reproducible
assessment in Quantitative Whole Body Autoradiography.
4 – 5 February, GMP meeting, Paris
How to improve QWBRLG strategy for the future ?
AnaBas
 : A routine tool for an accurate, reliable and reproducible
assessment in Quantitative Whole Body Autoradiography.
4 – 5 February, GMP meeting, Paris
How to improve QWBRLG strategy for the future ?
AnaBas
 : A routine tool for an accurate, reliable and reproducible
assessment in Quantitative Whole Body Autoradiography.
4 – 5 February, GMP meeting, Paris
How to improve QWBRLG strategy for the future ?
AnaBas
 : A routine tool for an accurate, reliable and reproducible
assessment in Quantitative Whole Body Autoradiography.
4 – 5 February, GMP meeting, Paris
How to improve QWBRLG strategy for the future ?
AnaBas
 : A routine tool for an accurate, reliable and reproducible
assessment in Quantitative Whole Body Autoradiography.
4 – 5 February, GMP meeting, Paris
How to improve QWBRLG strategy for the future ?
AnaBas
 : A routine tool for an accurate, reliable and reproducible
assessment in Quantitative Whole Body Autoradiography.
4 – 5 February, GMP meeting, Paris
How to improve QWBRLG strategy for the future ?
AnaBas
 : A routine tool for an accurate, reliable and reproducible
assessment in Quantitative Whole Body Autoradiography.
4 – 5 February, GMP meeting, Paris
How to improve QWBRLG strategy for the future ?
AnaBas
 : A routine tool for an accurate, reliable and reproducible
assessment in Quantitative Whole Body Autoradiography.
4 – 5 February, GMP meeting, Paris
How to improve QWBRLG strategy for the future ?
AnaBas
 : A routine tool for an accurate, reliable and reproducible
assessment in Quantitative Whole Body Autoradiography.
4 – 5 February, GMP meeting, Paris
How to improve QWBRLG strategy for the future ?
AnaBas
 : A routine tool for an accurate, reliable and reproducible
assessment in Quantitative Whole Body Autoradiography.
4 – 5 February, GMP meeting, Paris
How to improve QWBRLG strategy for the future ?
AnaBas
 : A routine tool for an accurate, reliable and reproducible
assessment in Quantitative Whole Body Autoradiography.
4 – 5 February, GMP meeting, Paris
How to improve QWBRLG strategy for the future ?
AnaBas
 : A routine tool for an accurate, reliable and reproducible
assessment in Quantitative Whole Body Autoradiography.
4 – 5 February, GMP meeting, Paris
How to improve QWBRLG strategy for the future ?
AnaBas
 : A routine tool for an accurate, reliable and reproducible
assessment in Quantitative Whole Body Autoradiography.
4 – 5 February, GMP meeting, Paris
How to improve QWBRLG strategy for the future ?
AnaBas
 : A routine tool for an accurate, reliable and reproducible
assessment in Quantitative Whole Body Autoradiography.
4 – 5 February, GMP meeting, Paris
How to improve QWBRLG strategy for the future ?
AnaBas
 : A routine tool for an accurate, reliable and reproducible
assessment in Quantitative Whole Body Autoradiography.
4 – 5 February, GMP meeting, Paris
How to improve QWBRLG strategy for the future ?
AnaBas
 : A routine tool for an accurate, reliable and reproducible
assessment in Quantitative Whole Body Autoradiography.
4 – 5 February, GMP meeting, Paris
How to improve QWBRLG strategy for the future ?
AnaBas
 : A routine tool for an accurate, reliable and reproducible
assessment in Quantitative Whole Body Autoradiography.
Benefits/Advantages
• Increase of accuracy in QTD when using WBA :
- Suppression of the mistake due to human eye error,
- ROI are defined from anatomical localization of tissues or organs across whole
body sections and not from the observation of the distribution of the radioactivity on
autoradiograms,
• Assessment to very low PSL or count values close to the background noise of
the detector becomes possible instead of not detectable and/or not quantifiable,
• Assessment to small organs and tissue parts without fine dissection process,
• Totally interfaced with the WBA interface of Debra LIMS (Lablogic, Sheffield,
UK),
• Full validated software compliant with GLP requirements and partially
21 CFR part 11 compliant,
4 – 5 February, GMP meeting, Paris
How to improve QWBRLG strategy for the future ?
AnaBas
 : A routine tool for an accurate, reliable and reproducible
assessment in Quantitative Whole Body Autoradiography.
Close future
• About "AnaBas" development :
- Integration in the application of a calibration function (expected in
version 3.0),
- Integration of an audit trail of the functions of administration of the application in
order to be full compliant with 21 CFR part 11 recommendation (expected in
version 3.0),
- Upgrade with texture, form and color algorithms for direct tissue recognition
(version ???)
• About steps before using AnaBas :
- Acquisition of digital images of non dehydrated sections during cross sectioning
(best colors and texture) using a numeric camera,
- Add a radioactive external standard during the inclusion of specimen in CMC to
allow three-dimensional re-built.
4 – 5 February, GMP meeting, Paris
How to improve QWBRLG strategy for the future ?
AnaBas
 : A routine tool for an accurate, reliable and reproducible
assessment in Quantitative Whole Body Autoradiography.
Contacts
• AnaBas package for quantitative nuclear analysis from Imaging Plate detection is
now available at:
Noésis
François Germain
6 – 8 rue de la Réunion
Les Ulis
F-91955 Courtaboeuf cedex
[email protected]
•AnaBas package for quantitative nuclear analysis from Direct Nuclear detection is
now available at:
Biospace Mesures
Marie Meynadier
10 rue Mercoeur
F-75011 Paris
[email protected]
4 – 5 February, GMP meeting, Paris
How to improve QWBRLG strategy for the future ?
AnaBas
 : A routine tool for an accurate, reliable and reproducible
assessment in Quantitative Whole Body Autoradiography.
Acknowledgments
To William Maio, in charge of the project for MPK Department
How to quantify
the invisible ? …
4 – 5 February, GMP meeting, Paris
How to improve QWBRLG strategy for the future ?
AnaBas
 : A routine tool for an accurate, reliable and reproducible
assessment in Quantitative Whole Body Autoradiography.
Acknowledgments
To Yves Collenot, in charge of the project for the IS Department
4 – 5 February, GMP meeting, Paris