Today, GE Healthcare has announced the first patient to be injected in the clinical trial in Phase III for a Positron Emission Tomography (PET) radiopharmaceutical imaging drug that aims to assist in assessing adults with suspected Parkinsonian syndromes, as well as support research and improve care for patients. Already a global leader with DaTscan ([123I]-ioflupane), used in Single-Photon Emission Computed Tomography (SPECT) imaging across more than 40 countries worldwide, GE Healthcare is now planning to bolster its portfolio with two pipeline radiopharmaceuticals, one for PET and one for SPECT.
The multi-center Phase III clinical trial of a PET radiopharmaceutical is underway in France. Alongside providing a possible shorter patient experience, The clinical trial is testing PET for dopamine transporter visualization in the striatal region with DaTscan. PET technology offers superior spatial resolution than SPECT, resulting in a more precise image that can assist in visual interpretation and diagnosis. The PET radiopharmaceutical first was created by Zionexa, the French company specializing in developing revolutionary radiopharmaceuticals purchased by GE Healthcare’s Pharmaceutical Diagnostics business last year.
The study’s lead researcher on the subject, Professor Olivier Rascol, Professor of Clinical Pharmacology at Toulouse University Hospital, explained: “We are excited to take part in this multi-center Phase 3 study that is a crucial moment in the creation of this drug. The availability of a PET option to detect dopamine transporters for patients suffering from Parkinsonian disorders could be essential for early diagnostic.”
A clinical trial of the next stage of a SPECT dopamine-transporter imaging agent is also being conducted in 2014 across the United States. The product is licensed by the Boston-based brain imaging specialist LikeMinds. It can cut down the overall time required for procedures, improve the workflow of imaging centers and improve the patient’s experience. GE Healthcare has obtained exclusive worldwide rights to the software.
“Dr. John Seibyl, Board Chairman and Distinguished Scientist at the Institute for Neurodegenerative Disorders, New Haven, Connecticut, stated: “This new SPECT agent could provide a quicker imaging process, which can give patients more comfort who are suspected of having Parkinsonian disorders and more effective for imaging clinics. The agent also has the potential of possibly creating dopamine-transporter images easier to access should it be it is approved.”
2024 was the tenth anniversary of GE Healthcare’s DaTscan in the U.S., used across the neurology field to assist in medical differentiation between disorders that suffer from dopaminergic neurodegeneration in the nigrostriatal region such as Parkinson’s Disease, as well as those that are not the condition, like Essential Tremor. DaTscan’s imaging occurs between 3 and 6 hours following the injection of radiotracers.
Julia Casey, Molecular Imaging General Manager of GE Healthcare Pharmaceutical Diagnostics, stated: “More than one million doses of DaTscan have already been administered around the globe to evaluate clinically Parkinsonian syndromes. In the wake of our success in this area and to enhance DaTscan we’re aiming to provide our customers both in research and clinical environments, with a broader selection of diagnostic tracers that span PET and SPECT that will meet every need. We will continue to invest in new products which allow the use of precision health, and could assist in improving outcomes in clinical trials.”
Globally there are a lot of Parkinson’s patients expected to increase by 2040. 6.9 million people in 2015. This will increase to 14.2 million by 2040 1. An early and accurate diagnosis assists patients and their families and caregivers in identifying the right resources and support needed and planning shortly to get treatments.
The GE Healthcare Pharmaceutical Diagnostics unit is a world-leading manufacturer of imaging agents used to aid in approximately 100 million procedures each year or three patients per second.
1 The Parkinson Pandemic – A Call to Action
- Ray Dorsey, MD1; Bastiaan R. Bloem, MD, PhD2
JAMA Neurol. 2018;75(1):9-10. doi:10.1001/jamaneurol.2017.3299
IMPORTANT SAFETY INFORMATION FOR DAT SCAN (IOFLUPANE I 123 INJECTION)
CONTRAINDICATIONS
- DaTscan is not recommended for patients who have a history of hypersensitivity to the active ingredient or all other excipients or the iodine.
WARNINGS AND PRECAUTIONS
- Hypersensitivity Reactions characterized mainly by pruritus and skin erythema are reported after DaTscan administration.
Thyroid Accumulation DaTscan may comprise up to 6.6% free Iodide (iodine I-123 or 123). To reduce thyroid accumulation of I-123, stop the thyroid gland for at least 1 hour before administering DaTscan. Failure to do this could increase the risk of thyroid neoplasia.
ADVERSE REACTIONS
- Clinical trials have observed headaches, nausea, vertigo, dizziness, dry mouth, or vertigo from mild to moderate intensity. In postmarketing experiences, hypersensitivity reactions and injection-site pain were reported.
DRUG INTERACTIONS
- Drugs that bind the dopamine transporter with a high affinity could interfere with the DaTscan images. The effect of dopamine agonists or antagonists in DaTscan image results is not yet established.
USE IN SPECIFIC POPULATIONS
- Pregnancy: Radioactive Iodine products pass through the placenta and may permanently affect the thyroid function. The administration of a thyroid-blocking medication is recommended before administering DaTscan to pregnant women. Every radiopharmaceutical has the potential to cause harm to the fetus. There aren’t any data available regarding DaTscan usage in pregnant women to determine the risk of drug-related congenital disabilities, miscarriage, or adverse results for the fetus or mother. Inform pregnant women about the dangers that could result from radiation exposure to the fetus during DaTscan.
The lactation process: Iodine 123 (I 123) I 123, the radionuclide found in DaTscan, is located within human milk. There isn’t any information about the effect of radionuclide on infants who are breastfed or in milk. If you are a lactating mom, discontinue breastfeeding and stop pumping and discarding breastfeeding milk at a minimum of 6 days after administering DaTscan to reduce radiation exposure for nursing infants.
Pediatric Use Safety and efficacy of DaTscan are not confirmed in children.
Geriatric Use: There were no variations in response between older and those who were younger that would need the adjustment of doses
The Renal and the Hepatic Impairment, The effect of hepatic or renal limitation on the DaTscan image hasn’t been determined. In the kidney, DaTscan is excreted. Those with severe renal impairment might be exposed to more radiation and altered DaTscan images.
OVERDOSAGE
- It is unclear the extent to which ioflupane could be dialyzable. The main risks associated with overdosage result from increased radiation exposure and a longer-term risk of neoplasia. In an overdose of radioactivity, regular urination and bowel defecation are recommended to limit radiation exposure to the patient.
PROCEDURE — Radiation Safety
- DaTscan emits radiation and must be handled with precautions to reduce radiation exposure for medical personnel and patients.
