An expanded access record providing [11C]Acetate in Prostate Cancer, sponsored by Wendell Yap, MD. No longer available at 1 site in United States. Open to male participants aged 45 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-05-16.
Sponsored by Wendell Yap, MD · Expanded access
When evaluating prostate cancer patients for recurrent disease, computed tomography (CT), and magnetic resonance imaging (MRI) are both highly sensitive methods for detecting lymph nodes, but are not specific as to whether the lymph nodes are malignant or benign.
While positron emission tomography (PET) utilizing radioactive glucose (FDG) has revolutionized staging, restaging, and monitoring response to therapy in many prevalent cancers such as breast, colorectal, esophageal, head and neck, lung, lymphoma, and melanoma, findings with prostate cancer have proven less sensitive because prostate cancer has a lower avidity for glucose. A newer PET isotope, utilizing acetate that is incorporated into the cell membrane of rapidly proliferating cells, has shown greater sensitivity than FDG in detecting prostate cancer.
This study will assess the clinical effectiveness of utilizing [11C]Acetate PET scans in identifying recurrent prostate cancer.
FDG-PET imaging uses a form of radioactive glucose (18-fluoro-deoxyglucose or FDG), which allows the measurement of glucose metabolic rate of any tissue in the body. The most prevalent tumors have a glucose avidity that is typically greater than 2.5 times the avidity of benign tissue. Therefore, FDG-PET is able to discriminate between benign lymph nodes and those containing metastases, and similarly between scar tissue and recurrence of tumor.
Unfortunately, prostate cancer is only minimally glucose avid, and therefore, FDG-PET is much less effective in staging prostate cancer. The current FDA-approved imaging agent for prostate cancer is a monoclonal antibody specific for prostate cancer cells, capromab pendetide, labeled with a long-lived radionuclide [111]Indium that is used to image the patient over a six day period. However, recent data show that another PET radiopharmaceutical, [11C]Acetate (which has been FDA approved for years for cardiac imaging), is avidly taken up by prostate metastasis and is more sensitive than either [111]Indium capromab pendetide or FDG-PET.
This study will assess the clinical effectiveness of utilizing [11C]Acetate PET scans in identifying recurrent prostate cancer and aim to find at what PSA levels it is most effective.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
Browse Prostatic Neoplasms studies →This is the only study on the registry with Wendell Yap, MD as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
intravenous injection of an average of 40 mCi of \[11C\]Acetate
Also known as: carbon-11 acetate [[11C]acetate], sodium acetate [11C]Acetate injection
Expanded access is arranged between your doctor and the company. Ask your care team to contact the provider listed on this record.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.