Status:
COMPLETED
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
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Colorectal Neoplasm
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
Positron Emission Tomography (PET scanning) is performed using a total dose of less than 50 mRad per patient visit. Fludeoxyglucose F 18 (FDG) is injected intravenously over 2 min. Initial dynamic ima...
Detailed Description
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 s...
Eligibility Criteria
All patients greater than 18 years old who have had a prior resection of colorectal cancer and are suspected of having recurrent disease.
Rising serum CEA levels greater than 6 on two successive tests.
Resectable residual or recurrent disease. Patients in the occult arm (Arm 1) must have no visible residual disease in the abdomen at the time of the last surgical exploration. In addition, there must be no imageable definitive site of recurrent disease using conventional imaging modalities including; CT scan of chest/ abdomen/ pelvis with contrast, MRI scan, and chest x-ray. Patients in arm 2 may have a single site of recurrent or metastatic disease which is resectable but in whom additional sites of disease are not known and no imageable disease other than a solitary site of potentially resectable disease is identified.
Patients must have an ECOG performance status of 0-1.
Patients must be willing to return to NIH for follow-up.
Patients must be able to provide informed consent as demonstrated by the signed consent.
Patients must be 2 or more months from abdominal or thoracic surgery.
No patients with medical contraindication to abdominal exploration.
No patients with recurrent disease detected by conventional imaging studies as outlined above. Metastatic disease localized outside of the abdominal cavity by conventional imaging studies as outlined above. Patients must weigh less than 136 kgs. which is the weight limit for the scanner tables.
No patients with previous injection of murine monoclonal antibodies: Human anti-mouse assay (HAMA) will be performed in patients with prior history of receiving murine monoclonal antibodies.
No patients that are pregnant or breast feeding.
Patients who are HIV + will be excluded.
Key Trial Info
Start Date :
February 1 1997
Trial Type :
INTERVENTIONAL
End Date :
October 1 2002
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00001568
Start Date
February 1 1997
End Date
October 1 2002
Last Update
March 4 2008
Active Locations (1)
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1
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892