As an example,
"For years we've been talking about precision health and theranostics as 'the future of healthcare.' Now, we are seeing it become a reality," says
Historically, medical treatments have been designed for the "average patient." As a result of this "one-size-fits-all" approach, treatments can be very successful for some, but not for others. Precision healthcare or personalized medicine, on the other hand, is an innovative approach that uses one's personal information and biomarkers - particularly genes, environments, and lifestyles - to help tailor treatment recommendations for individual patients[1]. This approach to healthcare has in turn given rise to theranostics, a new field of medicine that allows for targeted therapies because of clinically precise diagnostic tests.
To help clinicians more easily gather and interpret the vast amount of patient data needed to make more personalized care recommendations,
Nuclear Medicine (SPECT/CT)
Recently cleared by the FDA,
The ability to generate high-quality SPECT/CT images starts with StarGuide's unique Optical Scout technology, which leverages the system's efficiency-focused Swift Plan workflow to determine the contour of the patient body and set the rest of the clinical scanning procedure into motion. After processing the Optical Scout data, StarGuide's detectors and table automatically position themselves for close proximity and contactless scanning of the patient. The slim Digital Focus Detectors then orbit the body as closely as possible, and from all necessary angles, to scan the target area - and not the air surrounding the patient. The result is high-resolution images for clinicians and the minimization of time on the table for patients[3].
The excellent energy resolution of the
Market research shows that 73 percent of radiologists expect operational efficiency to be the main challenge in the next 1-3 years[5], while 64 percent of surveyed clinicians note that physician burnout has intensified during the pandemic[6]. These statistics highlight a growing need for increased flexibility, access, and efficiency in healthcare today.
With these statistics in mind, Xeleris V's new AI-enabled clinical applications work to streamline workflows, provide accurate data, and help expedite diagnoses across care areas: Q.Volumetrix AI, Q.Lung AI, and EXINI Bone.
PET/CT
Generated using a dedicated deep neural network, TrueFidelity CT Images have the potential to improve reading confidence in a wide range of clinical applications such as head, whole body and cardiovascular, for patients of all ages. The system also offers
Finally, Discovery MI Gen 2 is engineered for remote patient landmarking and positioning with AutoIN, which may aid in limiting contact with contagious diseases and unnecessary radiation exposure.
In
prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer, the third most common form of cancer in the United States[9], [10]. This approval is expected to increase demand for an already scarce PET imaging isotope: 68Gallium.
For many, a lack of access to radioisotopes can be a hinderance to practicing molecular imaging and precision health. Ongoing shortages of the generators that produce 68Gallium creates serious challenges for medical professionals treating a variety of patients.
Cyclotron produced 68Gallium is cheaper than generator production and provides a greater return on investment over the course of one year[11]. This is largely due to a cyclotron's ability to produce two times the amount of gallium chloride compared to a generator[12]. In the last 15 years, 68Gallium publications increasing 100x and clinician interest and use of Gallium continues to grow[13].
In
It is estimated that 168,000 people have metastatic breast cancer ("Stage 4") in the U.S.[14], with a five-year survival rate of 28 percent[15]. Cerianna has been commercially available in the
As the global leader in pharmaceutical imaging agents,
While there is still much work to be done in the field of theranostics and precision health, the full breadth of
For more information on
###
About
Follow us on Facebook, LinkedIn, Twitter, Instagram and Insights for the latest news, or visit our website www.gehealthcare.com for more information.
About Vizamyl:
Vizamyl (flutemetamol F18) is a radioactive diagnostic agent indicated for Positron Emission Tomography (PET) imaging of the brain to estimate ?-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD) or other causes of cognitive decline. A negative Vizamyl scan indicates sparse to no neuritic plaques, and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient's cognitive impairment is due to AD. A positive Vizamyl scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of neuritic plaque is present in patients with AD but may also be present in patients with other types of neurologic conditions, as well as older people with normal cognition. Vizamyl is an adjunct to other diagnostic evaluations
For more information about Vizamyl, please visit
About Cerianna:
Cerianna (fluoroestradiol F-18) is a new molecular imaging agent approved by the
For more information about Cerianna, please visit www.cerianna.com (accessible only for US HCPs) and find full prescribing information here.
Important Safety Information for Vizamyl(TM) (flutemetamol F 18) Injection
CONTRAINDICATIONS
Known hypersensitivity to Vizamyl or any excipient, including polysorbate 80
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions: Reactions such as flushing and dyspnea have been observed within minutes following administration and may occur in patients with no history of exposure to Vizamyl. Before administering Vizamyl, ask patients about prior reactions to drugs, especially those containing polysorbate 80. Have resuscitation equipment and trained personnel available
Risk for Image Misinterpretation and Other Errors: Errors may occur while interpreting Vizamyl positron-emission tomography (PET) images. Image interpretation is performed independently of the patient's clinical information. The use of clinical information in the interpretation of Vizamyl images has not been evaluated and may lead to errors. Extensive brain atrophy may limit the ability to distinguish grey and white matter on a Vizamyl scan. Motion artifacts may distort the image. Images should be interpreted only by readers who have completed a reader training program available from
Radiation Risk: Like all radiopharmaceuticals, Vizamyl contributes to a patient's long-term, cumulative radiation exposure and cancer risk. Ensure safe handling to protect patients and healthcare workers from unintentional radiation exposure
ADVERSE REACTIONS
The most commonly reported adverse reactions in clinical trials were flushing (2%), increased blood pressure (2%), headache (1%), nausea and dizziness (1%)
DRUG INTERACTIONS
Drug-drug interaction studies have not been performed in patients to establish the extent, if any, to which concomitant medications may alter Vizamyl image results
USE IN SPECIFIC POPULATIONS
Pregnancy: All radiopharmaceuticals, including Vizamyl, have potential to cause fetal harm. There are no available data on Vizamyl in pregnant woman to evaluate drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcome Advise women about the potential for adverse pregnancy outcomes based on the radiation dose and gestational timing of exposure
Lactation: There are no data on presence of flutemetamol or its metabolites in human milk. The benefits of breastfeeding should be considered along with the mother's clinical need for Vizamyl and any potential adverse effects on the breastfed child. Because many drugs are excreted in human milk and there is a potential for radiation exposure to nursing infants, advise a lactating woman to interrupt breastfeeding and pump and discard breast milk for 24 hours after administration to minimize radiation exposure to a breastfeeding infant
Pediatric Use: Vizamyl is not indicated for use in pediatric patients
Geriatric Use: No overall differences in safety were observed between older and younger subjects
OVERDOSAGE
The clinical consequence of overdosing with Vizamyl has not been reported. It is unknown whether or not flutemetamol is dialyzable. The major risks of overdosage relate to increased radiation exposure and long-term risk for neoplasia. In case of overdose of radioactivity, hydration and frequent urination should be encouraged
Prior to Vizamyl administration, please read the full Prescribing Information for additional Important Safety Information.
To report SUSPECTED ADVERSE REACTIONS, contact
Important Safety Information for Cerianna(TM) (fluroestradiol F 18) Injection
INDICATIONS AND USAGE
CERIANNA is indicated for use with positron emission tomography (PET) imaging for the detection of estrogen receptor (ER)-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer.
Limitations of Use
Tissue biopsy should be used to confirm recurrence of breast cancer and to verify ER status by pathology. CERIANNA is not useful for imaging other receptors, such as human epidermal growth factor receptor 2 (HER2) and the progesterone receptor (PR).
Important Safety Information
CONTRAINDICATIONS
None.
WARNINGS AND PRECAUTIONS
Risk of Misdiagnosis
Inadequate Tumor Characterization and Other ER-Positive Pathology
Breast cancer may be heterogeneous within patients and across time. CERIANNA images ER and is not useful for imaging other receptors such as HER2 and PR. The uptake of fluoroestradiol F 18 is not specific for breast cancer and may occur in a variety of ER-positive tumors that arise outside of the breast, including from the uterus and ovaries. Do not use CERIANNA in lieu of biopsy when biopsy is indicated in patients with recurrent or metastatic breast cancer.
False Negative CERIANNA Scan
A negative CERIANNA scan does not rule out ER-positive breast cancer. Pathology or clinical characteristics that suggest a patient may benefit from systemic hormone therapy should take precedence over a discordant negative CERIANNA scan.
Radiation Risks
Diagnostic radiopharmaceuticals, including CERIANNA, expose patients to radiation. Radiation exposure is associated with a dose-dependent increased risk of cancer. Ensure safe drug handling and patient preparation procedures (including adequate hydration and voiding) to protect patients and health care providers from unintentional radiation exposure.
Pregnancy Status
Assessment of pregnancy status is recommended in females of reproductive potential before administering CERIANNA.
ADVERSE REACTIONS
In Clinical Trials (n=1207) the most common adverse reactions seen occurred at a rate < 1%: were injection-site pain and dysgeusia.
USE IN SPECIFIC POPULATIONS
Pregnancy
Risk Summary
All radiopharmaceuticals, including CERIANNA, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of radiation dose. Advise a pregnant woman of the potential risks of fetal exposure to radiation from administration of CERIANNA.
There are no available data on CERIANNA use in pregnant women. No animal reproduction studies using fluoroestradiol F 18 have been conducted to evaluate its effect on female reproduction and embryo-fetal development.
The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the
Lactation
Risk Summary
There are no data on the presence of fluoroestradiol F 18 in human milk, or its effects on the breastfed infant or milk production. Lactation studies have not been conducted in animals. Advise a lactating woman to avoid breastfeeding for 4 hours after CERIANNA administration in order to minimize radiation exposure to a breastfed infant.
Pediatric Use
The safety and effectiveness of CERIANNA in pediatric patients have not been established.
Geriatric Use
Clinical studies of fluoroestradiol F 18 injection did not reveal any difference in pharmacokinetics or biodistribution in patients aged 65 and over.
DRUG INTERACTIONS
Systemic Endocrine Therapies that Target Estrogen Receptors
Certain classes of systemic endocrine therapies, including ER modulators and ER down-regulators, block ER, reduce the uptake of fluoroestradiol F 18, and may reduce detection of ER-positive lesions after administration of CERIANNA. Drugs from these classes such as tamoxifen and fulvestrant may block ER for up to 8 and 28 weeks, respectively. Do not delay indicated therapy in order to administer CERIANNA. Administer CERIANNA prior to starting systemic endocrine therapies that block ER.
To report SUSPECTED ADVERSE REACTIONS, contact
For media inquiries, please contact:
1 608 381 8829
.
(C) 2021 M2 COMMUNICATIONS, source