A GMP compliant production and delivery system under development for 15O-water.

We are developing a Point-of-Care GMP-compliant chemistry lab (MT-100) that combines the production of 15O-water with the infusion of the tracer into the patient – in one automated process. Connected to a cyclotron, the MT-100 converts the 15O-gas to 15O-water . A unique injection system delivers the tracer to the patient via venous catheter. MT-100 is currently not FDA approved nor CE-marked (medical device).

Stand-alone system

MT-100 has a height of approx. 60 in/150 cm.

Easy to operate

MT-100 can be operated from the machine itself or in the control room.

Self-shielded

MT-100 is shielded with 2 in/5 cm of lead.

HOW IT WORKS

A full cardiac examination consisting of both a rest and stress scan with two identical doses can be completed within 30 minutes. Due to the short half-life of only 122 seconds, the patient can stay on the scanner bed between scans removing the hassle of repositioning.

The MT-100 (A) is placed next to a PET-CT scanner (B) and connected to an onsite cyclotron (C). Both proton and deuteron cyclotrons are applicable. The cyclotron can be placed up to 1,600 feet/500 meters away from the PET scanner.

Four easy steps in 15O-water PET scanning.

Step 1

Once the patient and the PET scanner (B) are ready, the MT-100 (A) will call for 15O- gas from the connected cyclotron.

Step 2

The MT-100 will convert the 15O-gas (C) into 15O-water under GMP conditions, prepare the desired dose, and inject it into the patient in one automated process. Dose turnaround time can be less than 4 minutes.

Step 3

For cardiology, the procedure is repeated after a stress agent is injected. Due to the short half-life of 15O-water, the repeat scan can start only 10 minutes after the initial scan has started.

Step 4

Once the scan procedure is completed, the aQuant software can analyze the image data and provide the physician (D) with absolute cardiac flow values pr. cardiac segment and the cardiac ejection fraction.

Group 6Created with Sketch.

”The availability of a reliable approved system for bed-side production of 15O-water could change 15O-water PET from an exotic research tool to a clinical workhorse”

Martin Stenfeldt, CEO, MedTrace Pharma