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
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|ClinicalTrials.gov Identifier: NCT00001568|
Recruitment Status : Completed
First Posted : November 4, 1999
Last Update Posted : March 4, 2008
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 images will be obtained over the heart. Emission imaging will work from the midcervical region down to the perineal region.
For CEA scanning, radiolabeled antibody, arcitumomab (IMMU-4), is injected intravenously over 5 min. A single photon emission computed tomography (SPECT) transmission scan is performed over the same regions as the emission scans. Total dose from transmission scans should be no more than 20 mRad per patient visit.
Patients then undergo exploratory laparotomy performed by two surgeons, one blinded to the results of the CEA-Scan and PET scan.
At the completion of all exploration, all identified disease is biopsied for pathologic analysis and any resectable disease is removed.
Patients are followed every 3 months for 1 year, every 6 months for the second year, and then after 3 years.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Neoplasm||Drug: 2-Fluoro-2-deoxyglucose||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||200 participants|
|Official Title:||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|
|Study Start Date :||February 1997|
|Study Completion Date :||October 2002|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001568
|United States, Maryland|
|National Cancer Institute (NCI)|
|Bethesda, Maryland, United States, 20892|