On November 22, 2022 Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, reported that presentations on Axumin (fluciclovine F 18) at the upcoming Radiological Society of North America (RSNA) 108th Scientific Assembly and Annual Meeting, to be held in Chicago, Ill., from November 27 to December 1, 2022 (Press release, Blue Earth Diagnostics, NOV 22, 2022, View Source [SID1234624365]). Details of selected oral and poster presentations are listed below.
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Two presentations from Emory University will discuss additional analyses from EMPIRE-1, the first prospective, randomized controlled trial to demonstrate that 18F-fluciclovine PET/CT-guided radiation therapy improved event-free survival rates in men with biochemical recurrence of prostate cancer. Another presentation compares the diagnostic performance of bone scintigraphy with 18F-fluciclovine in detecting bone metastases in men with prostate cancer at various PSA levels. Details of selected oral and poster presentations by Blue Earth Diagnostics’ collaborators are listed below.
NOTE: Axumin (fluciclovine F 18) injection is FDA-approved for PET imaging in men with suspected prostate cancer recurrence based on elevated blood prostate-specific antigen (PSA) levels following prior treatment.
HIGHLIGHTED SCIENTIFIC PRESENTATIONS
Oral presentation
Thursday, December 1, 2022
Title:
Failure-free Survival of Prostate Cancer Patients After Conventional Imaging Versus 18F-fluciclovine PET-guided Salvage Radiotherapy Stratified by Serum PSA Level: A Secondary Sub-group Analysis of a Randomized Control Trial
Presenter:
Ismaheel Lawal, MD, Division of Nuclear Medicine and Molecular Imaging, Department of Radiology and Imaging Sciences, Emory University, Atlanta, Ga.
Session Type:
Oral Scientific Session
Session Title:
Science Session with Keynote: Nuclear Medicine/Molecular Imaging (Prostate Cancer Imaging)
Presentation Time:
1:30 – 2:30 PM CT
Location:
S402, McCormick Place
Presentation No.:
R-6-SNMMI 08-1
Poster presentations
Tuesday, November 29, 2022
Title:
Bone Scan versus F-18 Fluciclovine PET/CT at Different PSA Levels: A Single Center Comparison Study
Presenter:
Hatice Savas, MD, Associate Professor, Feinburg School of Medicine, Northwestern University, Chicago, Ill.
Session Type:
Scientific Poster Session
Session Title:
Nuclear Medicine/Molecular Imaging Tuesday Poster Discussion
Presentation Time:
9:00 – 9:30 AM CT
Location:
Learning Center NMMI-DPS, McCormick Place
Session No.:
T2-SPNMMI-1
Title:
Impact of 18F-fluciclovine PET/CT on Failure-free Survival in Biochemical Recurrence of Prostate Cancer Following Salvage Radiation Therapy
Presenter:
Charles Marcus, MBBS, Assistant Professor, Department of Imaging and Radiology Sciences, Emory University School of Medicine, Atlanta, Ga.
Session Type:
Scientific Poster Session
Session Title:
Nuclear Medicine/Molecular Imaging Tuesday Poster Discussion – A
Presentation Time:
12:15 – 12:45 PM CT
Location:
Learning Center NMMI-DPS, McCormick Place
Session No.:
T5A-SPNMMI-2
Axumin (fluciclovine F 18) presentations
Blue Earth Diagnostics invites participants at RSNA 2022 to attend the presentations above. For full session details and scientific presentation listings, please see the RSNA 2022 online program here.
Indication and Important Safety Information About Axumin
INDICATION
Axumin (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.
IMPORTANT SAFETY INFORMATION
Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.
Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.
Axumin use contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.
Adverse reactions were reported in ≤ 1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.
To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Full Axumin prescribing information is available at View Source