Ignite Creation Date:
2024-05-05 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001568
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief 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
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2002-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
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 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 97-C-0068 | None | None | None |