Document created November 11, 1996;
A murine monoclonal antibody fragment linked to 99mTc. CEA-Scan is reactive with carcinoembryonic antigen, a tumor marker for cancer of the colon and rectum. It is indicated with other standard diagnostic modalities for the detection of recurrent and/or metastatic colorectal cancer. CEA-Scan was approved June 26, 1996.
a murine monoclonal antibody Fab fragment linked to 111In. 111In Myoscint binds with high affinity and specificity to human cardiac myosin, which is exposed following a loss of integrity of the myocyte cell membrane. It is a cardiac imaging agent indicated for detecting the presence and location of myocardial injury in patients with suspected myocardial infarction. Use of Myoscint is anticipated in situations where electrocardiography and cardiac enzymes are nondiagnostic. Myoscint was approved July 3, 1996.
Verluma is a monoclonal antibody Fab fragment linked to 99mTc. Verluma identifies advanced-stage disease in patients with small-cell lung cancer (SCLC). The determination of disease stage has important prognostic and therapeutic implications. In the clinical trial involving 89 patients with confirmed SCLC, Tc-labeled Verluma accurately determined whether the disease was extensive or limited 82 percent of the time. If the test indicated extensive disease, the result was true in 94 percent of the patients. However, if the test indicated limited disease, it was less valuable as a diagnositc aid, failing to image tumors in some body organs in approximately 23 percent of the patients. Because of these false negative readings, additional standard diagnostic tests, such as a bone or CT scan or a bone marrow biopsy should be performed when limited disease is found. Verluma was approved August 20, 1996.
ProstaScint is a monocloncal antibody imaging agent linked to 111In. It seeks out and attaches to prostate cancer and its metastates. ProstaScint images can aid in patient management by helping identify when the cancer has spread outside the prostatic bed to regional lymph nodes or to distant soft tissue sites. Surgical resection of the prostate is not indicated for patients whose disease has spread outside the prostatic bed.
This document is copied from an article entitled "Radiolabeled Antibodies for Diagnostic Imaging" from the FDA which had this statement attached to it:
The FDA Medical Bulletin is in the public domain. Duplication is encouraged.
Also, this document was a handout at a biweekly inservice training at Beth Israel Deaconess Medical Center Nuclear Medicine Department led by Jeff Cone.
Document maintained by:Douglas J. Wagenaar, Ph.D., firstname.lastname@example.org