Finantare: Bugetul de stat
Tip proiect : PCCA Tip2
Cod Proiect: PN-II-PT-PCCA-2013-4-1105
Nr. Contract: 12/2014
Titlul proiectului: Innovative Medical System for Tumor Solid-Stress Monitoring to Improve Cancer Treatment, “TumorSense “
Valoarea totala a contractului: 1382846 lei
Din care pe surse de finantare:
Sursa 1: de la bugetul de stat: 1202344 lei
Sursa 2: din alte surse atrase(cofinantare proprie) : 180502 lei
Durata contractului: 36 luni
Autoritatea Contractanta: Unitatea Executiva pentru Finantarea Invatamantului Superior, a Cercetarii, Dezvoltarii si Inovarii
Parteneri: Universitatea de Medicina si Farmacie Iuliu Hatieganu, Cluj, Institutul National de Fizica Laserilor, Plasmei si Radiatiei, Bucuresti, SC IPA SA.
Director Proiect: Dr. Gabriel GRUIONU
Perioada: 1 iulie 2014 – 30 iunie 2016

Currently, cancer chemotherapy is not always effective because the growing tumor cells compress the blood vessels inside a tumor and subsequent chemotherapy delivered via the vascular system does not reach all areas of the tumor. Our company, SC MEDINSYS SRL has a track record of developing methods to improve cancer diagnosis and treatment via designing novel minimally invasive medical devices.

Recent scientific research in our collaborator laboratory, the Edwin L. Steele Laboratory for Tumor Biology from the Harvard Medical School, USA, demonstrated that the level of solid stress can be used as a biomarker for the response to chemotherapy. The lower the solid stress of a tumor is, the less compressed the tumor blood vessels are and the more effective the cancer therapy is.

The present project will build on these novel scientific results to improve cancer treatment. Specifically, the purpose of this project is to build and validate a catheter-based tumor micro sensor system (TumorSense) to be used by oncology surgeons to measure the mechanical stress within the tumor (solid stress). Currently, tumor biopsies are collected via a catheter-based biopsy needle at different stages during treatment to diagnose and stage the disease.

The proposed device will accurately measure the solid stress at the same time and site with the biopsy without disrupting the currently established diagnostic and treatment protocols. The specific goals of this project are to: 1) build a catheter-based solid stress tumor sensor; 2) develop an innovative medical system for tumor stress map investigation; and 3) develop a bench top and animal tissue testing system. The interdisciplinary team includes biomedical, mechanical, electrical and materials engineers, clinicians and scientists as well as product development managers.

The micro-sensor component prototype will be built by nano-technologies by Photonic Processing of Advanced Materials Group at Partner 2 (The National Institute for Laser, Plasma & Radiation Physics - INFLPR) from novel piezo-electric, biocompatible, nanostructured thin films obtained by pulsed laser deposition (PLD), reactive PLD and MAPLE (matrix assisted pulsed laser evaporation).

The micro sensor will be assembled into a catheter fit into an endoscope’s working channel, connected to a computer and tested on a bench top model by MEDINSYS. They will are also responsible to add the electromagnetic guidance component to orient the solid stress sensor in the tumor.

The animal tissue testing will be performed at the Partner 1 (University of Medicine and Pharmacy from Cluj-Napoca). The data analysis system will be developed by electrical engineering team from the Partner 3 (IPA - private institute for R&D in automation and IT field). This will be the first micro-sensor and minimally invasive system to measure the solid stress in a human soft tissue.

The TumorSense will also use a novel catheter-based system and electromagnetic tracking sensor to guide the micro sensor precisely into the tumor. The patent will be shared between members of our team and our collaborators at the Harvard Medical School, USA who first discovered the role of the solid stress as a biomarker for cancer treatment. Monitoring tumor solid stress with a minimally invasive procedure will significantly increase the efficacy and reduce the cost of the cancer treatment by eliminating unnecessary and ineffective treatment, and optimizing the delivery of effective medicine.

Read here the project details (romanian)


Finantare: Bugetul de stat
Tip proiect : PCCA Tip2
Cod Proiect: PN-II-PT-PCCA-2011-3.2-0482
Nr. Contract: 87/2012
Valoarea totala a contractului: 2166380 lei
Din care pe surse de finantare:
Sursa 1: de la bugetul de stat: 1727300 lei
Sursa 2: din alte surse atrase(cofinantare proprie) : 439080 lei
Durata contractului: 36 luni
Autoritatea Contractanta: Unitatea Executiva pentru Finantarea Invatamantului Superior, a Cercetarii, Dezvoltarii si Inovarii
Parteneri: SC IPA SA, SC ONCOLAB SRL, Institutul National de Pneumologie Prof. Dr. Marius NastaDirector
Proiect: Conf. Dr. Ing. Lucian GRUIONU
Perioada: 1 august 2012 - 31 iulie 2015

Currently, to diagnose lung cancer, pulmonologists plan the transbronchial biopsy procedure by examining a number of Computed Tomography (CT) scan slices before the procedure. They then manipulate a flexible fiber-optic bronchoscope into segmental and sub-segmental bronchi as far as the diameter of the bronchoscope permits. Finally, they insert a biopsy forceps through the working channel of the bronchoscope, and blindly perform the biopsy. Consequently, 43% of the procedures fail to reach peripheral targets. When these failures occur, pulmonologists must repeat the procedure or follow up with more invasive methods that have increased complication rates, such as CT-guided percutaneous needle biopsy with increased level of radiation for surgeon and patient or surgical biopsy with high stress for patient. In low income countries like Romania, CT-guided interventional procedures are available only in a limited number of medical centers due to the high cost of equipment and lack of specialized personnel. We propose to overcome these limitations and enhance the accuracy and guidance, and decrease the procedure time and learning curve of transbronchial biopsy by developing an innovative minimally invasive image-guided system (named TransBITE) that uses an innovative steerable and electromagnetically tracked biopsy forceps. To achieve this long-term goal, in the present proposal we plan to develop a working prototype of the TransBITE system including an electromagnetically tracked forceps and test it in a custom-designed innovative human body respiratory mannequin developed also in the project. After the successful completion of this project, the system will be further developed by the SME partners of this consortium (3 private companies are involved and cofound) for further phantom and animal studies, clinical trials and medical approvals.

Read here the project details (romanian)


Design and development of an innovative system, TRIGER, for endoscopic ultrasound (EUS) with CT-US image registration and real-time position tracking of the instrument. Using fiducials placed on the patient skin through initial CT (or MR) investigation and electromagnetic tracking equipment, TRIGER registers the patient and imaging data in the USendoscopy operating room. A special tool with an electromagnetic sensor placed in the endoscopic working channel is used to track the medical instrument inside the patient during procedure.

TRIGER displays in real-time the endoscope position on a 3D model of the patient developed from CT cross sections offering an improved orientation for the surgeon during procedure. The system furthermore displays on the same screen the ultrasound image and a virtual section through CT data corresponding to the endoscope position resulting in enhanced visual information for accurate diagnostic. In present, the TRIGER system is under clinical testing.

Read here the project summary (romanian)


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Global Medical Product Development, Ltd.

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