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FDA Approves Production of PET Agent for Prostate Cancer
The FDA has approved the production and use of PET imaging agent Choline C 11 injection for identifying recurrent prostate cancer.
The FDA has approved the production and use of PET imaging agent Choline C 11 injection for identifying recurrent prostate cancer.
The Mayo Clinic in Rochester, Minn., was cleared as the first facility to manufacture Choline C 11 injections, the agency announced.
Choline C 11 has been used for several years, but the new approval procedures and good manufacturing practice requirements under the FDA Modernization Act opened the door for specialized facilities to produce the imaging agent.
PET imaging with Choline C 11 is used in patients who have rising levels of blood prostate specific antigen (PSA), the protein produced by the prostate gland. Elevated PSA levels can indicate a cancer recurrence even when traditional imaging studies, such as CT scans, show no signs of the disease. Choline C 11 injections help pinpoint the site of prostate cancers in recurrent cases when these other imaging tests come back negative.
Mayo Clinic researchers published a study on the efficacy of Choline C 11 injections in patients with recurrent prostate cancer in 2011 in the Journal of Nuclear Medicine. This research determined Choline C 11 use enhances prostate cancer lesion detection by roughly 30 percent.
FDA Approves Fluorescence Imaging System for Detecting Residual Breast Cancer
April 18th 2024The combination of the optical imaging agent Lumisight and the fluorescence imaging device Lumicell Direct Visualization System, collectively known as LumiSystem, reportedly offers 84 percent accuracy with real-time detection of residual breast cancer after lumpectomy procedures.
Study of Ofatumumab for Multiple Sclerosis Shows 'Profoundly Suppressed MRI Lesion Activity'
April 17th 2024The use of continuous ofatumumab in patients within three years of a relapsing multiple sclerosis diagnosis led to substantial reductions in associated lesions on brain MRI scans, according to research recently presented at the American Academy of Neurology (AAN) conference.
Could a Deep Learning Model for Mammography Improve Prediction of DCIS and Invasive Breast Cancer?
April 15th 2024Artificial intelligence (AI) assessment of mammography images may significantly enhance the prediction of invasive breast cancer and ductal carcinoma in situ (DCIS) in women with breast cancer, according to new research presented at the Society for Breast Imaging (SBI) conference.
