Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004891
Status:
COMPLETED
Last Update Posted:
2015-12-22
First Post:
2000-03-07
Brief Title:
PET and CT Scans in Patients With Locally Advanced Primary Rectal Cancer That Can Be Removed During Surgery
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Prospective Evaluation of 18F-Fluorodeoxyglucose Positron Emission Tomography FDG-PET in the Multimodality Management of Locally Advanced Primary Rectal Cancer
Status:
COMPLETED
Status Verified Date:
2015-12
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:
RATIONALE Diagnostic procedures such as PET and CT scans may improve the ability to detect the extent of locally advanced primary rectal cancer and may also help to measure a patients response to treatment
PURPOSE This clinical trial is studying how well PET and CT scans detect residual or metastatic disease in patients with locally advanced primary rectal cancer that can be removed during surgery
PURPOSE This clinical trial is studying how well PET and CT scans detect residual or metastatic disease in patients with locally advanced primary rectal cancer that can be removed during surgery
Detailed Description:
OBJECTIVES
Determine if fludeoxyglucose F 18 positron emission tomography FDG-PET is superior to CT scan at monitoring rectal cancer response to radiation and chemotherapy by identifying residual rectal cancer in the rectal wall or pelvic lymph nodes in order to optimize selection of patients suitable for a sphincter preserving rectal cancer resection or a local excision
Determine the accuracy of FDG-PET in detecting extrapelvic metastatic disease in primary rectal cancer patients considered operable on the basis of currently accepted diagnostic work-up including abdominal CT scan and chest x-ray
OUTLINE This is a diagnostic study conducted concurrently with multimodality management
Within 1-2 weeks prior to starting preoperative radiotherapychemotherapy patients undergo baseline positron emission tomography PET imaging of the thorax abdomen and pelvis Patients receive fludeoxyglucose F 18 FDG IV followed 45 minutes later by PET imaging Patients also undergo baseline CT imaging of the abdomen and pelvis A CT scan of the chest is obtained if the prestudy chest x-ray is abnormal
Patients receive preoperative radiotherapychemotherapy Within 4-6 weeks of completion of radiotherapychemotherapy patients undergo repeat FDG-PET imaging and CT scan Patients undergo surgical resection 1-2 weeks later
PROJECTED ACCRUAL A total of 125 patients will be accrued for this study within 3 years
Determine if fludeoxyglucose F 18 positron emission tomography FDG-PET is superior to CT scan at monitoring rectal cancer response to radiation and chemotherapy by identifying residual rectal cancer in the rectal wall or pelvic lymph nodes in order to optimize selection of patients suitable for a sphincter preserving rectal cancer resection or a local excision
Determine the accuracy of FDG-PET in detecting extrapelvic metastatic disease in primary rectal cancer patients considered operable on the basis of currently accepted diagnostic work-up including abdominal CT scan and chest x-ray
OUTLINE This is a diagnostic study conducted concurrently with multimodality management
Within 1-2 weeks prior to starting preoperative radiotherapychemotherapy patients undergo baseline positron emission tomography PET imaging of the thorax abdomen and pelvis Patients receive fludeoxyglucose F 18 FDG IV followed 45 minutes later by PET imaging Patients also undergo baseline CT imaging of the abdomen and pelvis A CT scan of the chest is obtained if the prestudy chest x-ray is abnormal
Patients receive preoperative radiotherapychemotherapy Within 4-6 weeks of completion of radiotherapychemotherapy patients undergo repeat FDG-PET imaging and CT scan Patients undergo surgical resection 1-2 weeks later
PROJECTED ACCRUAL A total of 125 patients will be accrued for this study within 3 years
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 |
|---|---|---|---|
| NCI-G00-1695 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000067567 | REGISTRY | None | None |