Diagnostic Breath Tests
Application of Substrates Labeled with Carbon-13 Isotope for Breath Testing
Tech Area / Field
- MED-DID/Diagnostics & Devices/Medicine
- MED-DRG/Drug Discovery/Medicine
3 Approved without Funding
National High Technology Center of Georgia, Georgia, Tbilisi
- Georgian AIDS and Clinical Immunology Research Center, Georgia, Tbilisi\nTbilisi State Medical University / Research Institute of Experimental and Clinical Medicine, Georgia, Tbilisi
- Isonics Corporation, USA, NJ, Edgewater\nMukogawa Women's University, Faculty of Pharmaceutical Sciences, Japan, Nishinomiya\nSt. Elisabeth/ St. Petrus Joint Hospital, Germany, Bonn\nFriedrich-Schiller-Universitat, Germany, Jena
Project summaryChronical liver diseases are one of the basic problems in the healthcare all over the world. They cause a very high rate of mortality, hospitalization and invalidity in the world.
Quantitative assessment of the various aspects of liver function can provide clinically valuable information on the heaviness, natural development, and prediction of the liver disease, and on the effect of the therapeutic treatment. In clinics quantitative tests of the liver function are based on various liver functions and reflect blood supply to the liver, its functional and metabolic state and exchange between the blood and hepatocyte. All these tests have their own drawbacks and limitations, while breath tests (BT) are more convenient and simple. They are non-invasive, simple, safe, which is a great advantage of the method. Results of serial BT have shown they effectively assess the rate of the liver damage, provide useful information on the state of the liver disease.
13C-methacetin breath tests for monitoring the quantitative liver function seems to be the most promising for medical practice. 13C-methacetin is metabolized by P450 cytochrome (O-demethylation) into 13CO2 and acetaminophene. After peroral admission of 13C-methacetin 13CO2 is measured in the expired air by an isotope-selective spectrometer.
To achieve the goals of the project the following tasks should be fulfilled:
1. To develop the method for medical grade 13C-methacetin synthesis.
2. To develop methods of analytical control over the initial, intermediate and final products of synthesis. To develop methods for certifying the final product, 13C-methacetin for medical application.
3. To monitor safety of methacetin, labeled with 13C isotope for live bodies.
4. To develop, standardize and study 13C-methacetin-based breath test (BT) for measuring liver quantitative function.
5. To study 13C-methacetin-based BT to test the quantitative liver function in healthy volunteers and in patients with various liver diseases: acute liver diseases (of various aetiology) and chronical liver diseases (of various aetiology).
6. To compare BT results, based on imported standard 13C-methacetin and on a similar domestic-made preparation.
7. To compare the results of 13C-methacetin BT with those of common tests of liver functions, Dopler ultrasonography, ezophagogastrofibroscopy, liver biopsy in health people ann in patients with various liver diseases;
8. To check the accuracy, sensitivity and specificity of 13C-methacetin (imported and home-made) breath test for each of the above nosologies.
9. To use imported 13C-methacetin BT 13C-methacetin BT of domestic production to control the efficacy of various methods of treatment in patients, suffering from various chronical liver diseases.
10. To prepare and submit to the Georgian Health Ministry the necessary documentation on the introduction of 13C-methacetin based BT method for quantitative assessment of liver function into the clinical practice of Georgia.
Researchers, who earlier used to deal with the development and improvement of weapon technologies are the basic staff to launch the Project. The Project will allow to re-orient and integrate these specialists into the healthcare system.
Basic expected results:
1. Production technology of methacetin, labeled with carbon-13 isotope, as the substrate for diagnostic breath test for liver quantitative function will be developed.
2. Diagnostic screening breath test of various liver pathologies will be developed for application in clinical practice.