Updated NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Recommend Use of FES PET Imaging for Lobular Breast Cancer
ARLINGTON HEIGHTS, Ill.--(BUSINESS WIRE)--May 30, 2025--
GE HealthCare (Nasdaq: GEHC) today announced that the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ® ) for clinicians now recommend considering fluoroestradiol (FES) positron emission tomography (PET) for systemic staging in patients with recurrent or metastatic lobular breast cancer. GE HealthCare's Cerianna™ (fluoroestradiol F18) injection, available in the United States, is the only FDA-approved imaging agent for the detection of estrogen receptor positive (ER+) breast cancer metastases, including lobular breast cancer. The updated NCCN Guidelines ® expand the recommendation for the use of FES PET imaging in ER+ disease. In 2023, FES PET was included in the NCCN Guidelines for systemic staging of recurrent/stage IV ER+ breast cancer.
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PET/CT scan with Cerianna™ (fluoroestradiol F18) injection for patient with ILC reveals bone metastases
According to the Breast Cancer Research Foundation, 95% of invasive lobular cancer (ILC) tumors are ER+. i ILC is the second most common type of breast cancer in the U.S., accounting for 10-15% of all breast cancers and an estimated 43,000 new cases each year. iiiiiiv Lobular tumors typically do not form lumps which makes the cancer harder to detect with self-exams, mammography, ultrasound and magnetic resonance imaging (MRI). ILC can also recur more than a decade v after initial diagnosis and metastasize to unusual places such as the bones, brain, liver, lungs, gynecological organs, and others. vivii Once recurrent or metastatic lobular breast cancer is suspected, the new guidelines recommend considering FES PET imaging of the whole body to assess whether ER+ lobular tumors are present.
'Lobular cancers are often missed during routine screening, which can result in larger, more advanced tumors when they are finally detected and diagnosed,' said Jit Saini, MD, Chief Medical Officer of the Pharmaceutical Diagnostics (PDx) division of GE HealthCare. 'This NCCN Guidelines update is significant because it will give more oncologists the confidence to use Cerianna PET imaging for patients with lobular breast cancer. It may also facilitate broader insurance coverage so more patients with this common, but hard-to-detect cancer will have an opportunity to receive a comprehensive diagnosis that accelerates clinical decisions and early intervention.'
Cerianna is a molecular imaging agent indicated for use with PET imaging for the detection of ER+ lesions as an adjunct to biopsy in patients with known or suspected recurrent or metastatic breast cancer. Cerianna works by binding to functional ER lesions and then the whole body is imaged by PET scan to help doctors assess and treat lobular breast cancer appropriately. With its diffuse growth patterns, detection and biopsy of ILC can be more difficult. Cerianna provides an alternative method to assess ER status across the whole body.
The recommendation that FES PET may be appropriate in lobular histology was established by an expert working group convened by the Society of Nuclear Medicine and Molecular Imaging (SNMMI) and included breast care specialists from the SNMMI, Lobular Breast Cancer Alliance, American College of Nuclear Medicine and Korean Society of Nuclear Medicine. The SNMMI is a nonprofit organization that promotes the science, technology and practical application of nuclear medicine and molecular imaging.
The National Comprehensive Cancer Network (NCCN ® ) is a not-for-profit alliance of 33 leading U.S. cancer centers devoted to patient care, research, and education. The NCCN Guidelines are the recognized standard for clinical direction and policy in cancer care and the most thorough and frequently updated clinical practice guidelines available in any area of medicine.
GE HealthCare's Pharmaceutical Diagnostics segment is a global leader in imaging agents used to support around 130 million procedures per year globally, equivalent to four patient procedures every second. Its Molecular Imaging portfolio combines established proprietary products across cardiology, neurology and oncology, with an innovative pipeline, all aimed at enabling better informed diagnosis and monitoring for improved therapy decision making and clinical outcomes. Learn more about Cerianna here: https://www.gehealthcare.com/products/molecular-imaging-agents/cerianna.
About GE HealthCare Technologies Inc.
GE HealthCare is a trusted partner and leading global healthcare solutions provider, innovating medical technology, pharmaceutical diagnostics, and integrated, cloud-first AI-enabled solutions, services and data analytics. We aim to make hospitals and health systems more efficient, clinicians more effective, therapies more precise, and patients healthier and happier. Serving patients and providers for more than 125 years, GE HealthCare is advancing personalized, connected and compassionate care, while simplifying the patient's journey across care pathways. Together, our Imaging, Advanced Visualization Solutions, Patient Care Solutions and Pharmaceutical Diagnostics businesses help improve patient care from screening and diagnosis to therapy and monitoring. We are a $19.7 billion business with approximately 53,000 colleagues working to create a world where healthcare has no limits.
GE HealthCare is proud to be among 2025 Fortune World's Most Admired Companies™.
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NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
IMPORTANT SAFETY INFORMATION FOR CERIANNA™ (FLUORESTRADIOL F18) 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
WARNINGS AND PRECAUTIONS
Risk of Misdiagnosis
Inadequate Tumor Characterization and Other ER-Positive Pathology
False Negative CERIANNA Scan
Radiation Risks
Pregnancy Status
ADVERSE REACTIONS
USE IN SPECIFIC POPULATIONS
Pregnancy
Risk Summary
Lactation
Risk Summary
Pediatric Use
Geriatric Use
DRUG INTERACTIONS
Systemic Endocrine Therapies that Bind to ER
Prior to Cerianna administration, please read the full Prescribing Information and additional Important Safety Information here.
To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 800 654 0118 (option 2 then option 1) or by email at[email protected]or FDA at 800 FDA 1088 orwww.fda.gov/medwatch
JB11825US 2025
View source version on businesswire.com:https://www.businesswire.com/news/home/20250530411032/en/
CONTACT: GE HealthCare Media Contact:
Emmy Elguizaoui
Communications Director – USCAN
[email protected]
KEYWORD: ILLINOIS UNITED STATES NORTH AMERICA
INDUSTRY KEYWORD: TECHNOLOGY GENERAL HEALTH PROFESSIONAL SERVICES NEUROLOGY SCIENCE DATA ANALYTICS CARDIOLOGY BIOTECHNOLOGY HEALTH HEALTH TECHNOLOGY OTHER SCIENCE RESEARCH OTHER HEALTH RADIOLOGY DATA MANAGEMENT ARTIFICIAL INTELLIGENCE ONCOLOGY
SOURCE: GE HealthCare
Copyright Business Wire 2025.
PUB: 05/30/2025 09:20 AM/DISC: 05/30/2025 09:18 AM
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