Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00253461
Status:
TERMINATED
Last Update Posted:
2012-03-20
First Post:
2005-11-11
Brief Title:
11C Topotecan PET Imaging
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Positron Emission Tomography Using 11C Topotecan in Predicting Response to Treatment in Patients With Brain Metastases Due to Ovarian Small Cell Lung or Other Cancer
Status:
TERMINATED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Drugs unavailableunable to make radioactive topotecan
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 positron emission tomography PET scan using 11C topotecan may help doctors predict a patients response to treatment and help plan the best treatment
PURPOSE This phase III trial is studying how well a PET scan using 11C topotecan predicts response to treatment in patients with brain metastases due to ovarian small cell lung or other cancer
PURPOSE This phase III trial is studying how well a PET scan using 11C topotecan predicts response to treatment in patients with brain metastases due to ovarian small cell lung or other cancer
Detailed Description:
OBJECTIVES
Primary
Determine if tumor uptake of 11C topotecan occurs quickly enough and at sufficient concentration to be measured immediately following infusion in patients with brain metastases secondary to ovarian cancer small cell lung cancer or other cancers
Determine preliminarily if 11C imaging has potential to be an early predictor of response to topotecan therapy in these patients
Secondary
Determine the whole-body biodistribution of 11C topotecan in these patients
OUTLINE
Phase I Patients receive 11C topotecan IV over 10 minutes followed immediately by a 1-2 hour positron emission tomography PET scan Within 4 weeks after initial imaging patients also undergo a CT scan
Phase II Patients receive 11C topotecan and undergo imaging as in phase I Patients also receive fludeoxyglucose F 18 IV and 1 hour later undergo a PET scan
PROJECTED ACCRUAL A total of 10 patients will be accrued for this study
Primary
Determine if tumor uptake of 11C topotecan occurs quickly enough and at sufficient concentration to be measured immediately following infusion in patients with brain metastases secondary to ovarian cancer small cell lung cancer or other cancers
Determine preliminarily if 11C imaging has potential to be an early predictor of response to topotecan therapy in these patients
Secondary
Determine the whole-body biodistribution of 11C topotecan in these patients
OUTLINE
Phase I Patients receive 11C topotecan IV over 10 minutes followed immediately by a 1-2 hour positron emission tomography PET scan Within 4 weeks after initial imaging patients also undergo a CT scan
Phase II Patients receive 11C topotecan and undergo imaging as in phase I Patients also receive fludeoxyglucose F 18 IV and 1 hour later undergo a PET scan
PROJECTED ACCRUAL A total of 10 patients will be accrued for this study
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 |
|---|---|---|---|
| CASE-CWRU-6Y02 | OTHER | Case Comprehensive Cancer Center | httpsreporternihgovquickSearchP30CA043703 |
| P30CA043703 | NIH | None | None |