Dosing Begins in Phase 3 Trial of PET Agent for Parkinsonian Syndromes

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by Patricia Inacio PhD |

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The first patient has been dosed in a Phase 3 trial testing GE Healthcare’s new dopamine transporter positron emission tomography (PET) tracer, which is designed to aid in the evaluation of adults with suspected parkinsonian syndromes, including Parkinson’s disease.

The PET agent is a radiolabeled tracer molecule that allows the visualization of dopamine activity in the brain, which is defective in people with Parkinson’s.

Researchers say the new tracer may allow for faster imaging scans, which could be more efficient — and more convenient for patients.

The tracer originally was developed by Zionexa, a French company, which has been acquired by GE Healthcare’s Pharmaceutical Diagnostics.

The clinical trial, underway in France, will compare PET with GE Healthcare’s DaTscan, a specific type of single-photon emission computed tomography (SPECT) imaging technique, to visualize dopamine transporter levels in the brain.

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PET and SPECT are both nuclear medicine imaging techniques that measure tissue metabolism but differ in the type of radiotracers they use: positron-emitting radioisotopes in PET and gamma-emitting radioisotopes in SPECT.

Most importantly, PET imaging has a higher spatial resolution, meaning it is better at detecting small and distinguishing close objects, than SPECT. This will aid the interpretation of the scans and allow for more accurate diagnoses.

“We are excited to conduct this multi-center Phase III study which represents a significant milestone in the development of this radiopharmaceutical,” Olivier Rascol, a professor at Toulouse University Hospital, in France, said in a press release.

“Having a PET option for dopamine transporter imaging in patients with Parkinsonian syndromes could be highly relevant for an early differential diagnosis,” Rascol added.

The new PET agent will enhance GE Healthcare’s portfolio for tracers to be used in the diagnosis of people with parkinsonian syndromes, as well as in research and care.

“Building on our leadership in this space, and to complement DaTscan, we are aiming to offer our customers, in both clinical and research settings, a wider choice of diagnostic tracers across PET and SPECT to suit all needs. We continue to invest in products that enable precision health and may help improve clinical outcomes,” said Julia Casey, Molecular Imaging general manager for GE Healthcare’s Pharmaceutical Diagnostics.

GE Healthcare also will conduct a clinical study in the U.S. of another SPECT dopamine transporter imaging agent. Originally developed by LikeMinds, a Boston-based brain imaging specialist, this radiotracer allows for a reduction in time for the overall evaluation, allowing for more exams to be conducted and improving patients’ comfort. The company has the exclusive global rights for this new SPECT agent.

“This new SPECT agent may offer a faster imaging workflow which could provide more convenience for patients with suspected Parkinsonian syndromes and greater efficiency for the imaging clinic,” said John Seibyl, MD, board chairman for the Institute for Neurodegenerative Disorders, in New Haven, Connecticut.

“It also holds promise in potentially making dopamine transporter imaging more accessible if approved,” he said.