The purpose of these prospective, pivotal studies was to assess the performance and the potential clinical impact of a new antibody imaging agent, CEA-Scan(TM), in 210 presurgical patients with advanced recurrent or metastatic colorectal carcinomas. CEA-Scan(TM), an anti-carcinoembryonic antigen (CEA) Fab' antibody fragment labeled with 99mTc, was injected IV and external scintigraphy performed 2-5 h and 18-24 h later. Imaging with conventional diagnostic modalities (CDM) was also performed, and findings were confirmed by surgery and histology. The sensitivity of CEA-Scan(TM) was superior to that of CDM in the extrahepatic abdomen (55% vs 32%, p = 0,007) and pelvis (69% vs 48%, p = 0,005), and CEA-Scan(TM) findings complemented those of CDM in the liver. Among 122 patients with known disease, the positive predictive value was significantly higher when both modalities were positive (98%) as compared to each alone (68%-70%), potentially obviating the need for histological confirmation when both tests are positive. Imaging accuracy also was significantly improved by adding CEA-Scan(TM) to CDM. In 88 patients with occult cancer, imaging accuracy was enhanced significantly by CEA-Scan(TM) combined with CDM (61% vs 33%). Potential clinical benefit from CEA-Scan(TM) was demonstrated in 89 of 210 patients. Only two patients developed human antimouse antibodies (HAMA) to CEA-Scan(TM) after a single injection, and none of 19 assessable patients after two injections.
|Translated title of the contribution||Clinical utility of immunoscintigraphy with the Immu-4 99mTc-Fab' antibody fragment in patients undergoing surgery for carcinoma of the colon and rectum|
|Number of pages||9|
|State||Published - Jan 1 1996|
- Tc-anti-CEA antibody
ASJC Scopus subject areas
- Radiology Nuclear Medicine and imaging
- Radiological and Ultrasound Technology