Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004152
Status:
COMPLETED
Last Update Posted:
2013-01-16
First Post:
1999-12-10
Brief Title:
PET and CT Scans to Evaluate Patients With Stage III or Stage IV Melanoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Pilot Study to Compare 18F-Fluorodeoxyglucose Positron Emission Tomography PET Scanning in Addition to CT Scanning With CT Scanning Alone in the Pre-Operative Evaluation of Patients With Stage III and IV Melanoma
Status:
COMPLETED
Status Verified Date:
2013-01
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 may improve the ability to detect metastatic melanoma and to determine the extent of disease
PURPOSE Phase II trial to evaluate the effectiveness of PET and CT scans to detect metastatic disease in patients who have stage III or stage IV melanoma
PURPOSE Phase II trial to evaluate the effectiveness of PET and CT scans to detect metastatic disease in patients who have stage III or stage IV melanoma
Detailed Description:
OBJECTIVES I Evaluate the sensitivity specificity and accuracy of fludeoxyglucose F 18 FDG positron emission tomography PET imaging in detecting metastatic disease in patients with stage III or IV melanoma considered for operative management based on the currently accepted diagnostic work up including CT imaging II Determine how often the clinical management of these patients is altered based on FDG PET imaging findings in addition to CT scan results
OUTLINE Patients are required to fast for a minimum of 6 hours prior to positron emission tomography PET imaging Fludeoxyglucose F 18 FDG is administered IV over 15 minutes followed 50-60 minutes later by whole body PET imaging Iodinated contrast dye is administered by IV injection and by mouth followed by CT imaging of the chest abdomen and pelvis within 2 weeks of PET imaging Whole body FDG PET imaging and CT imaging of the chest abdomen and pelvis are repeated at 6 months Initial positive PET or CT imaging results are verified based on surgical andor biopsy findings or clinical follow-up
PROJECTED ACCRUAL A total of 100 patients will be accrued for this study within 25 years
OUTLINE Patients are required to fast for a minimum of 6 hours prior to positron emission tomography PET imaging Fludeoxyglucose F 18 FDG is administered IV over 15 minutes followed 50-60 minutes later by whole body PET imaging Iodinated contrast dye is administered by IV injection and by mouth followed by CT imaging of the chest abdomen and pelvis within 2 weeks of PET imaging Whole body FDG PET imaging and CT imaging of the chest abdomen and pelvis are repeated at 6 months Initial positive PET or CT imaging results are verified based on surgical andor biopsy findings or clinical follow-up
PROJECTED ACCRUAL A total of 100 patients will be accrued for this study within 25 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-G99-1619 | None | None | None |
| MSKCC-99004 | None | None | None |