Phase II Study of the Role of Anti-CEA Antibody Immunoscintigraphy & Positron Emission Tomography in the Localization of Recurrent Colorectal Carcinoma in Patients With Rising Serum CEA Levels in the Absence of Imageable Disease by Conventional Modalities
Recurrences following resection for colorectal carcinoma occur in 50% of patients. Early
detection and management of recurrences results in improved survival. Post-operative
surveillance consists of serial CT scans, chest x-rays, colonoscopy and CEA determinations.
Elevations in the serum CEA level can be the earliest and most sensitive indicator of
recurrence. A rise in the serum CEA level in the absence of imageable disease presents a
particular diagnostic challenge. Advanced imaging modalities such as Positron Emission
Tomography (PET) and anti-CEA antibody immunoscintigraphy have been proposed as a way of
localizing disease in these patients. This study will evaluate the sensitivity,
specificity, accuracy and predictive value of FDG-PET scans and anti-CEA immunoscintigraphy
in patients following resection of colorectal carcinoma who have rising serum CEA values in
the absence of imageable disease by conventional modalities. Patients who meet inclusion
criteria will undergo FDG-PET scan and anti-CEA immunoscintigraphy followed by an
exploratory laparotomy. Abdominal explorations will be conducted by two surgeons, one of
whom will be blinded to the results of the FDG-PET and CEA scans. All suspicious lesions
will be biopsied and if possible resected. Results at operation will be correlated with the
results of the scans. The goal of the study is to determine the role of FDG-PET scanning
and anti-CEA immunoscintigraphy in the localization of recurrent colorectal carcinoma in
patients with rising serum CEA levels.
Interventional
Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
United States: Federal Government
970068
NCT00001568
February 1997
October 2002
Name | Location |
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National Cancer Institute (NCI) | Bethesda, Maryland 20892 |