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KVAL: A kit for molecular imaging of kidney function using Positron Emission Tomography

Tildelt: kr 0,50 mill.




2022 - 2022

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Vi har utviklet et nytt konsept for å visualisere og kvantifisere enkelt nyrefunksjon direkte, rask og med overlegen selektivitet uten behov for blod- eller urinprøvetaking. Oppfinnelsen reduserer tiden som kreves for å undersøke nyrefiltreringsfunksjonen fra flere timer eller dager ned til minutter, noe som tillater tidlig sykdomsdeteksjon og forbedret opplevelse for pasienter og nyredonorer. Konseptet er basert på Positron Emission Tomography (PET) avbildning av glomerulær filtrasjonshastighet (GFR). Dette prosjektet skal verifisere konseptet for kliniske studier og videre kommersialisering. Prosjektets suksess er avhengig av positive resultater fra tester på griser, å konkludere med probene som skal brukes på mennesker samt riktig dosering for kliniske studier. Videre vil den bru av metoden på nyredonere verifiseres og evalueres i samarbeid med partnere.

With this qualification project we have taken important steps towards commercialisation of the PET GFR concept. A successful commercialisation of the PET GFR measurement concept can significantly improve kidney transplantation procedures, both reducing cost and time but also raising quality in the investigation of donor and receiver and by this raise the safety and lower stress on the patient and donor. In addition, the method has potential to improve kidney surgery procedures by providing means to verify results of surgery, faster and more detailed than what is possible today. Finally, the method has potential to contribute to early diagnosis of kidney diseases in general, and unilateral diseases specifically. All milestones have been met and the project have shown positive results from tests in pigs, fulfilling the go/no-go milestone. The path to market for a PET-tracer is however long and it is expected that a commercialisation of the method is still several years into the future.

We have developed a novel concept to visualize and quantify single kidney function direct, fast and with superior selectivity without the need for blood or urine sampling. The invention decreases the time required for investigating kidney filtration function from multiple hours or days down to minutes, allowing early disease detection and improved experience for patients and kidney donors. The concept is based on Positron Emission Tomography (PET) imaging of Glomerular Filtration rate (GFR) following i.v. injection of an endogenous molecule labelled with 18F. Knowledge of the glomerular filtration rate (GFR) is of crucial importance in the handling of patients and potential kidney donors. GFR is widely accepted as the best overall measure of kidney function and there is a strong correlation between reduced GFR and mortality. The presently available methods for GFR measurements however possess serious limitations. They are lengthy and cumbersome for the patients and clinicians often rely on non-functional imaging modalities or inaccurate blood test in their decision making. In addition, today only the collective function of both kidneys is assessed. Serious perturbations in one kidney may remain undiagnosed since the contralateral kidney usually compensates for the loss of function while it is still healthy. Kidney PET functional imaging is underutilized because of lack of disease-specific molecular probes. The PET GFR solution presented in this project presents a unique and innovative concept that offer exactly such a probe. This project will verify the concept for clinical studies and further commercialization. The success of the project is pending on positive results from tests in pigs, to conclude on the 18F-probes to be used in humans and the correct dosage for clinical trials. Furthermore, the primary use case will be verified and evaluated in collaboration with partners.